FEBRUARY 2012

WEEK ENDING FEBRUARY 25

PRODUCT GE Healthcare Signa, Discovery and Optima. Signa HDe 1.5T; Signa Infinity TwinSpeed MR System, 1.5T Infinity TwinSpeed, Signa Lx; Signa Infinity MR System with EXCITE Technology, Excite II, Signa Excite 1.5T Expert; Signat 3T Infinity with Excite; Signa 3.0T with EXCITE; Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T; Signa HDx; Signa HDxt; Signa Vibrant; Signa HDi; Signa Horizon Cx aka MR/I; Discovery MR450; Discovery MR750; Optima MR450w; Signa Cvi, and Signa Nvi. The Optima MR45Ow is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. it is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body. The indication for use includes, but is not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Optima MR450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and spectra, when interpreted by a trained physician yield information that may assist in diagnosis. 
CODE Lot #’s: 5147788-5, 5139394, and 5139394-2; 2199859 and 2202900-6; 5148810 and 5373011; 5148810-2 and 5373011-2; 5148810-3, 5148810, and 5373011
RECALLING FIRM/MANUFACTURER GE Healthcare, LLC, Waukesha, WI, 
REASON GE Healthcare has become aware of missing labels on the alignment lasers.
VOLUME OF PRODUCT IN COMMERCE 4614 units
DISTRIBUTION Nationwide

 

PRODUCT The EnCor biopsy probe, designed for use with EnCor and EnCor Enspire Vacuum Assisted Biopsy (VAB) driver systems. The EnCor Biopsy Device is indicated for use in acquiring tissue for diagnosing breast abnormalities and is supplied sterile and intended for single use. 
CODE Units: ECP0110G, ECP017G, ECP0112G, ECPMR0110G, ECP017GV, ECPMR0110GBT, ECP0112GV, ECPMR017G
RECALLING FIRM/MANUFACTURER Bard Peripheral Vascular Inc., Tempe, AZ, 
REASON Product’s damaged packaging trays.
VOLUME OF PRODUCT IN COMMERCE 64,570 units
DISTRIBUTION Nationwide, Canada, Europe, LAPAC, and Australia

 

PRODUCT
1) Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
 
2) Ingenuity CT computed Tomography System, Model #728326, 510(k) #KK 033326, Serial Numbers: 300010 and 300018. The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. 
CODE
1) Serial Numbers: 95504, 91003, 300030, 95130, and 95157;
2) Serial Numbers: 300010 and 30
RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 
REASON Software errors. A number of non-conformances were logged during in-house testing and external validation testing of Brilliance 64 and Ingenuity CT software version 4.0 Beta 2. The non-conformances are due to software errors identified in these device systems.
VOLUME OF PRODUCT IN COMMERCE 7 units
DISTRIBUTION Nationwide, of Australia, China, Belgium, Israel, and Sweden

 

PRODUCT Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; list 09K14. 
CODE All serial numbers
RECALLING FIRM/MANUFACTURER Abbott Molecular, Des Plaines, IL, 
REASON Abbott Molecular has received reports in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated and/or caught fire.
VOLUME OF PRODUCT IN COMMERCE 432 units
DISTRIBUTION Nationwide and Internationally

 

PRODUCT Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise Suite 1.3, Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1. A medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from variety of imaging devices. 
CODE
Vital ID 10013 10079 10082 10092 10099 10104 10112 10117 10126 10127 10141 10149 10150 10158 10161 10174 10186 10199 10200 10210 10224 10225 10226 10227 10236 10250 10276 10300 10305 10306 10327 10351 10355 10359 10364 10380 10394 10395 10396 10400 10409 10412 10413 10415 10416 10418 10432 10437 10478 10487 10491 10499 10533 10539 10574 10575 10592 10607 10610 10613 10633 10635 10637 10656 10664 10665 10671 10685 10691 10697 10698 10709 10729 10732 10737 10739 10741 10748 10753 10767 10796 10798 10800 10802 10806 10827 10834 10859 10870 10878 10879 10880 10898 10921 10968 10991 11033 11088 11093 11119 11129 11136 11150 11165 11168 11178 11185 11233 11235 11252 11260 11262 11263 11269 11271 11280 11287 11289 11310 11316 11333 11342 11359 11366 11401 11404 11412 11444 11483 11513 11544 11555 11597 11613 11623 11684 11696 11776 11827 11888 11922 11941 11991 12043 12118 12122 12226 27622 27658 27674 27694 27729 27766 27774 27833 27849 27879 27889 27893 27908 27933 27958 27992 27994 28041 28076 28179 28194 28228 28236 28243 28263 28356 28405 28455 28470 28510 28516 28547 28552 28559 28567 28582 28603 28667 28668 28716 28724 28746 28808 28882 28914 28915 28917 28920 28921 28939 28956 28958 29007 29009 29010 29017 29024 29025 29026 29087 29088 29097 29154 29155 29156 29157 29158 29167 29229 29271 29281 29290 29340 29341 29351 29372 29373 29375 29376 29507 29546 29551 29557 29569 29570 29573 29574 29583 29586 29601 29603 29606 29607 29609 29610 29623 40108 40117 40131 40163 40176 40192 40284 40295 40325 40513 40565 40614 40617 40647 40706 40714 40722 40739 40771 40926 41109 41145 41194 41230 41256 41439 41461 41507 41539 41596 41674 41981 42093 42153 42521 42873 42934 43369 43503 43536 43557 43635 43669 43720 45759 45960 46274 46672 47454 47920 48344 52042 52976 53018 53025 53033 53055 53117 53175 53194 53196 53197 53443 53535 53537 53544 53672 53673 53744 53745 53748 53897 53898 54012 54022 54102 54318 54821 54822 54827 54830 54863 54945 55005 55008 55063 55302 55327 55375 55901 56015 56185 57343 28591 40391
RECALLING FIRM/MANUFACTURER Vital Images, Inc., Plymouth, MN, 
REASON Vital Images has found two issues that may display incorrect Standard Update Values (SUV) when viewing certain PET/CT images. This issue affects the VitreaCore PET/CT feature for Vitrea Enterprise Suite 1.2, 1.3, 6.0, 6.1, including all updates to those versions.
VOLUME OF PRODUCT IN COMMERCE 338 (233 US)
DISTRIBUTION Nationwide and Internationally

 

PRODUCT Kotex Natural Balance Security tampons, regular absorbency, unscented. packaged in 18 count or 36 count retail containers. To absorb menstrual or other vaginal discharge. 
CODE Lot numbers (found in the red box located on bottom of package): AC129321X, AC129421X, AC129521X, AC129621X, AC129721X, AC129821X, AC129921X 36 count: AC129325X, AC129425X, AC129525X, AC129625X, AC129725X, AC129825X, AC129925X
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kimberly-Clark Corp., Roswell, GA,
REASON A limited number of Kotex Natural Balance Security Unscented Tampons, regular absorbency, are being recalled after a raw material contaminated with a bacterium, Enterobacter sakazakii, was found when testing the plunger portion of the applicator.
VOLUME OF PRODUCT IN COMMERCE 1,400 cases (216 tampons per case)
DISTRIBUTION Nationwide

 

PRODUCT Box labeled in part, "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L) RABALON, STAINLESS STEEL, GOLD PLATED***NON-STERILE PRODUCT ***" The Biomet Microfixation IQ Intelligent Driver is a handheld cordless device designed for three functions: drill pilot holes, high-speed insertion of 1.5x4mm titanium screws, and high-speed insertion of 1.5x4mm and 1.5x5mm Lactosorb fixation screws provided by Biomet Microfixation. The IQ Intelligent Driver is indicated to aid in the implantation of screws (Drilling holes and inserting screws). Model #- 72-1000. 
CODE
Serial #'s: 000007, 000009, 000010, 000011, 000012, 000013, 000017, 0G0014, 0G0018, 0G0019, 0K0001, 0K0003, 0K0006, 0K0007, 0K0008, 0K0009, 0K0011, 0K0012, 0K0013, 0K0014, 0K0015, 0K0016, 0K0017, 0K0019, 0K0020, 0K0021, 0K0022, 0L0001, 0L0002, 0L0003, 0L0004, 0L0005, 0L0006, 0L0007, 0L0008, 0L0009, 0L0010, 0L0011, 0L0014, 0L0015, 0L0016, 0L0017, 0L0018, 0L0019, 0L0020, 0L0022, 0L0023, 0L0024, 0L0026, 0L0028, 0L0029, 0L0030, 0L0031, 0L0032, 0L0033, 0L0034, 0L0035, 0L0037, 0L0038, 0L0039, 0L0041, 0L0042, 0L0044, 0L0045, 0L0046, 1A0004, 1A0005, 1A0012, 1A0014, 1A0016, 1A0019, 1A0020, 1A0021, 1A0022, 1A0024, 1A0026, 1A0028, 1A0031, 1A0033, 1A0034, 1A0036, 1A0037, 1A0041, 1A0042, 1A0043, 1A0044, 1A0046, 1A0047, 1A0048, 1A0051, 1A0052, 1A0053, 1A0055, 1A0056, 1A0057, 1A0059,1A0062, 1A0064, 1A0067, 1A0069, 1A0070, 1A0072, 1A0073, 1A0079, 1A0081, 1A0084, 1A0085, 1A0086, 1A0088, 1A0089, 1A0090, 1A0091, 1A0093, 1A0095, 1A0096, 1A0097, 1A0098, 1A0099, 1A0100, 1A0101, 1A0102, 1A0103, 1A0105, 1A0106, 1A0107, 1A0108, 1A0113, 1A0117, 1A0118, 1A0119, 1A0120, 1A0123, 1A0125, 1A0126, 1A0127, 1A0128, 1A0129, 1A0130, 1A0131, 1A0133, 1A0134, 1A0135, 1A0136, 1A0137, 1A0138, 1A0142, 1A0144, 1A0145, 1A0148, 1A0149, 1A0152, 1A0153, 1A0156, 1A0158, 1A0171, 1A0174, 1A0176, 1A0198, 1B0010, 1C0004, 1C0014, 1C0023, 1C0025, CK 0030, CK0011, CK0024, CK0025, CK0026, CK0027, CK0028, CK0029, CK0032, CK0033
RECALLING FIRM/MANUFACTURER Biomet Microfixation, Inc., Jacksonville, FL,
REASON Recall due to failure of the front bit sensor to detect the correct bit that is installed. When a screw is inserted with the device in drill mode, it is possible for the screw or bone to strip.
VOLUME OF PRODUCT IN COMMERCE 161 units
DISTRIBUTION Nationwide and Internationally

 

PRODUCT ThermoSuit. Temperature reduction in patients where clinically indicated; Monitoring of patient temperature.
CODE Units: 510 K K061023 N0110PD N0108NI N0068JH N0109PD N0103NE N0106NI N0065JH N0104NI N0105NI
RECALLING FIRM/MANUFACTURER
Recalling Firm: Life Recovery Systems HD, LLC, Waldwick, NJ, 
Manufacturer: Nexcore Technology, Inc., Waldwick, NJ. 
REASON ThermoSuit System Model TSP-50 Pump/Controller may have corrosion on the temperature circuit board which may result in incorrect patient temperature reading.
VOLUME OF PRODUCT IN COMMERCE 28 units
DISTRIBUTION Nationwide

 

PRODUCT
1) Varian Unique Single Energy Linear Accelerator, C-Series Clinac or Trilogy, versions 7.x and 8.x, Reference/FSCA Identifier: CP-0661; Model Numbers: H14, H18, H27, H29; Varian Unique Single Energy Linear Accelerator: The UNIQUE is a Single Energy Linear Accelerator intended to be used for conventional radiotherapy and includes modifications to the previously cleared Varian Trilogy. The UNIQUE provides additional features, safety improvements, and usability improvements. The UNIQUE is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. 
 
2) Varian High Energy Linear Accelerator, C-Series Clinac, Reference/FSCA Identifier: CP-06611; Models Numbers: 600C, 600CD, 6EX, DBX, 2100C, 2100CD, 2300CD, 21EX, 23EX, DMX, DHX versions 2.x through 6.x. The Varian High Energy Linear Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. 
CODE
1) H140001 ,H140145 ,H140711 ,H140772 ,H140832 ,H140893 ,H140958 ,H271265 ,H271742 ,H272014 ,H272235 ,H272416 ,H272858 ,H140011 ,H140146 ,H140712 ,H140773 ,H140833 ,H140895 ,H140959 ,H271277 ,H271755 ,H272016 ,H272236 ,H272418 ,H272859 ,H140018 ,H140147 ,H140713 ,H140774 ,H140834 ,H140896 ,H140962 ,H271293 ,H271760 ,H272023 ,H272237 ,H272421 ,H272860 ,H140025 ,H140148 ,H140714 ,H140775 ,H140835 ,H140897 ,H140963 ,H271308 ,H271762 ,H272029 ,H272239 ,H272422 ,H272862 ,H140026 ,H140150 ,H140715 ,H140776 ,H140836 ,H140898 ,H180455 ,H271334 ,H271763 ,H272031 ,H272240 ,H272423 ,H272864 ,H140027 ,H140151 ,H140716 ,H140777 ,H140837 ,H140899 ,H182000 ,H271362 ,H271773 ,H272033 ,H272243 ,H272425 ,H272866 ,H140029 ,H140152 ,H140717 ,H140778 ,H140838 ,H140900 ,H182001 ,H271370 ,H271780 ,H272035 ,H272250 ,H272426 ,H272868 ,H140031 ,H140153 ,H140718 ,H140779 ,H140839 ,H140901 ,H182002 ,H271378 ,H271783 ,H272043 ,H272259 ,H272427 ,H272872 ,H140038 ,H140154 ,H140719 ,H140780 ,H140840 ,H140902 ,H182003 ,H271385 ,H271785 ,H272045 ,H272260 ,H272428 ,H272873 ,H140039 ,H140201 ,H140720 ,H140781 ,H140841 ,H140903 ,H182005 ,H271393 ,H271797 ,H272049 ,H272271 ,H272432 ,H272876 ,H140043 ,H140202 ,H140721 ,H140782 ,H140842 ,H140904 ,H182006 ,H271407 ,H271801 ,H272050 ,H272277 ,H272434 ,H272885 ,H140045 ,H140203 ,H140722 ,H140783 ,H140843 ,H140905 ,H182007 ,H271413 ,H271802 ,H272052 ,H272283 ,H272438 ,H272889 ,H140046 ,H140204 ,H140723 ,H140784 ,H140844 ,H140906 ,H182008 ,H271414 ,H271811 ,H272062 ,H272290 ,H272440 ,H272890 ,H140047 ,H140205 ,H140724 ,H140785 ,H140845 ,H140907 ,H182009 ,H271420 ,H271825 ,H272064 ,H272291 ,H272444 ,H272893 ,H140048 ,H140206 ,H140725 ,H140786 ,H140846 ,H140908 ,H182010 ,H271425 ,H271831 ,H272069 ,H272293 ,H272445 ,H272899 ,H140058 ,H140207 ,H140726 ,H140787 ,H140847 ,H140909 ,H182011 ,H271429 ,H271833 ,H272078 ,H272299 ,H272446 ,H272905 ,H140062 ,H140208 ,H140727 ,H140788 ,H140848 ,H140910 ,H182012 ,H271438 ,H271835 ,H272081 ,H272301 ,H272454 ,H272908 ,H140067 ,H140209 ,H140728 ,H140789 ,H140849 ,H140911 ,H182013 ,H271439 ,H271838 ,H272085 ,H272302 ,H272456 ,H272909 ,H140070 ,H140210 ,H140729 ,H140790 ,H140850 ,H140912 ,H182014 ,H271440 ,H271845 ,H272086 ,H272306 ,H272458 ,H272910 ,H140071 ,H140211 ,H140730 ,H140791 ,H140851 ,H140913 ,H182016 ,H271443 ,H271853 ,H272089 ,H272307 ,H272460 ,H272911 ,H140073 ,H140212 ,H140731 ,H140792 ,H140852 ,H140914 ,H182017 ,H271452 ,H271856 ,H272111 ,H272309 ,H272462 ,H272912 ,H140076 ,H140213 ,H140732 ,H140793 ,H140853 ,H140915 ,H182018 ,H271490 ,H271858 ,H272115 ,H272310 ,H272464 ,H272914 ,H140077 ,H140214 ,H140733 ,H140794 ,H140854 ,H140916 ,H182019 ,H271497 ,H271860 ,H272118 ,H272311 ,H272466 ,H272922 ,H140078 ,H140215 ,H140734 ,H140795 ,H140855 ,H140917 ,H182020 ,H271502 ,H271862 ,H272129 ,H272313 ,H272469 ,H272926 ,H140079 ,H140216 ,H140735 ,H140796 ,H140856 ,H140918 ,H182021 ,H271507 ,H271866 ,H272134 ,H272318 ,H272470 ,H272932 ,H140088 ,H140217 ,H140736 ,H140797 ,H140857 ,H140919 ,H182022 ,H271515 ,H271870 ,H272136 ,H272321 ,H272473 ,H272933 ,H140090 ,H140218 ,H140737 ,H140798 ,H140858 ,H140920 ,H182023 ,H271519 ,H271872 ,H272137 ,H272324 ,H272476 ,H272936 ,H140092 ,H140219 ,H140738 ,H140799 ,H140859 ,H140921 ,H182030 ,H271523 ,H271875 ,H272138 ,H272325 ,H272479 ,H272938 ,H140096 ,H140220 ,H140739 ,H140800 ,H140860 ,H140922 ,H182032 ,H271526 ,H271877 ,H272143 ,H272326 ,H272480 ,H272941 ,H140097 ,H140221 ,H140740 ,H140801 ,H140861 ,H140923 ,H260905 ,H271531 ,H271879 ,H272153 ,H272327 ,H272488 ,H272946 ,H140098 ,H140222 ,H140742 ,H140802 ,H140862 ,H140924 ,H260909 ,H271534 ,H271881 ,H272155 ,H272328 ,H272491 ,H272951 ,H140101 ,H140223 ,H140743 ,H140803 ,H140863 ,H140925 ,H260922 ,H271559 ,H271890 ,H272156 ,H272329 ,H272492 ,H272953 ,H140107 ,H140224 ,H140744 ,H140804 ,H140864 ,H140926 ,H260924 ,H271582 ,H271893 ,H272157 ,H272333 ,H272494 ,H272956 ,H140109 ,H140225 ,H140745 ,H140805 ,H140865 ,H140927 ,H260925 ,H271587 ,H271895 ,H272158 ,H272336 ,H272497 ,H272960 ,H140111 ,H140226 ,H140746 ,H140806 ,H140866 ,H140929 ,H260928 ,H271588 ,H271896 ,H272159 ,H272339 ,H272500 ,H272961 ,H140113 ,H140227 ,H140747 ,H140807 ,H140867 ,H140930 ,H260931 ,H271593 ,H271903 ,H272162 ,H272341 ,H272801 ,H272963 ,H140114 ,H140228 ,H140748 ,H140808 ,H140868 ,H140931 ,H260936 ,H271594 ,H271905 ,H272163 ,H272343 ,H272803 ,H272964 ,H140115 ,H140229 ,H140749 ,H140809 ,H140869 ,H140932 ,H260940 ,H271602 ,H271906 ,H272168 ,H272345 ,H272804 ,H272968 ,H140116 ,H140230 ,H140750 ,H140810 ,H140870 ,H140933 ,H260942 ,H271607 ,H271918 ,H272169 ,H272346 ,H272805 ,H272971 ,H140117 ,H140231 ,H140751 ,H140811 ,H140871 ,H140934 ,H260946 ,H271618 ,H271921 ,H272172 ,H272349 ,H272806 ,H272973 ,H140118 ,H140232 ,H140752 ,H140812 ,H140872 ,H140935 ,H260949 ,H271624 ,H271926 ,H272173 ,H272354 ,H272811 ,H272978 ,H140119 ,H140233 ,H140753 ,H140813 ,H140873 ,H140936 ,H260950 ,H271626 ,H271931 ,H272174 ,H272355 ,H272816 ,H272981 ,H140121 ,H140234 ,H140754 ,H140814 ,H140874 ,H140937 ,H260951 ,H271628 ,H271935 ,H272178 ,H272359 ,H272820 ,H272982 ,H140122 ,H140235 ,H140755 ,H140815 ,H140875 ,H140938 ,H260952 ,H271635 ,H271941 ,H272179 ,H272360 ,H272822 ,H272985 ,H140124 ,H140236 ,H140756 ,H140816 ,H140876 ,H140939 ,H260953 ,H271640 ,H271942 ,H272180 ,H272362 ,H272824 ,H272986 ,H140125 ,H140237 ,H140757 ,H140817 ,H140877 ,H140940 ,H270767 ,H271662 ,H271951 ,H272184 ,H272365 ,H272825 ,H272987 ,H140129 ,H140238 ,H140758 ,H140818 ,H140878 ,H140941 ,H270788 ,H271663 ,H271954 ,H272187 ,H272370 ,H272826 ,H272990 ,H140132 ,H140239 ,H140759 ,H140819 ,H140879 ,H140942 ,H270794 ,H271664 ,H271961 ,H272188 ,H272372 ,H272827 ,H272993 ,H140133 ,H140240 ,H140760 ,H140820 ,H140881 ,H140943 ,H271041 ,H271669 ,H271964 ,H272195 ,H272377 ,H272828 ,H272996 ,H140134 ,H140700 ,H140761 ,H140821 ,H140882 ,H140944 ,H271066 ,H271678 ,H271972 ,H272197 ,H272380 ,H272834 ,H272999 ,H140135 ,H140701 ,H140762 ,H140822 ,H140883 ,H140945 ,H271105 ,H271681 ,H271973 ,H272202 ,H272381 ,H272837 ,H273003 ,H140136 ,H140702 ,H140763 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,H295173 ,H295279 ,H294448 ,H294512 ,H294581 ,H294644 ,H294707 ,H294772 ,H294836 ,H294901 ,H294969 ,H295034 ,H295102 ,H295174 ,H295281 ,H294449 ,H294513 ,H294582 ,H294645 ,H294708 ,H294773 ,H294837 ,H294902 ,H294970 ,H295035 ,H295103 ,H295176 ,H295282 ,H294450 ,H294514 ,H294583 ,H294646 ,H294709 ,H294774 ,H294838 ,H294903 ,H294971 ,H295036 ,H295105 ,H295177 ,H295284 ,H294451 ,H294515 ,H294584 ,H294647 ,H294710 ,H294775 ,H294839 ,H294904 ,H294972 ,H295037 ,H295106 ,H295178 ,H295287 ,H294452 ,H294516 ,H294585 ,H294648 ,H294711 ,H294776 ,H294840 ,H294905 ,H294974 ,H295038 ,H295107 ,H295179 ,H295290 ,H294454 ,H294517 ,H294586 ,H294649 ,H294712 ,H294777 ,H294841 ,H294906 ,H294975 ,H295039 ,H295108 ,H295180 ,H295291 ,H294455 ,H294518 ,H294587 ,H294650 ,H294713 ,H294778 ,H294842 ,H294907 ,H294976 ,H295040 ,H295109 ,H295181 ,H295299 ,H294457 ,H294519 ,H294588 ,H294651 ,H294714 ,H294779 ,H294843 ,H294908 ,H294977 ,H295041 ,H295110 ,H295182 ,H295300 ,H294458 ,H294520 ,H294589 ,H294652 ,H294715 ,H294780 ,H294844 ,H294910 ,H294978 ,H295042 ,H295111 ,H295183 ,H295301 ,H294459 ,H294521 ,H294590 ,H294653 ,H294716 ,H294781 ,H294845 ,H294911 ,H294979 ,H295043 ,H295112 ,H295184 ,H294460 ,H294522 ,H294591 ,H294654 ,H294717 ,H294782 ,H294846 ,H294912 ,H294980 ,H295044 ,H295114 ,H295185 ,H294461 ,H294523 ,H294592 ,H294655 ,H294718 ,H294783 ,H294847 ,H294914 ,H294981 ,H295045 ,H295116 ,H295186 ,H294462 ,H294524 ,H294593 ,H294656 ,H294719 ,H294784 ,H294848 ,H294915 ,H294982 ,H295046 ,H295117 ,H295188 ,H294463 ,H294525 ,H294594 ,H294657 ,H294720 ,H294785 ,H294850 ,H294916 ,H294983 ,H295047 ,H295118 ,H295193 ,H294464 ,H294526 ,H294595 ,H294658 ,H294723 ,H294786 ,H294851 ,H294917 ,H294984 ,H295048 ,H295119 ,H295195 ,H294465 ,H294527 ,H294596 ,H294659 ,H294724 ,H294787 ,H294853 ,H294918 ,H294986 ,H295049 ,H295120 ,H295196 ,H294466 ,H294528 ,H294597 ,H294660 ,H294726 ,H294788 ,H294854 ,H294919 ,H294987 ,H295050 ,H295121 ,H295199 ,H294467 ,H294529 ,H294598 ,H294661 ,H294727 ,H294789 ,H294855 ,H294920 ,H294988 ,H295051 ,H295122 ,H295201 ,H294468 ,H294530 ,H294599 ,H294662 ,H294728 ,H294790 ,H294856 ,H294921 ,H294989 ,H295053 ,H295123 ,H295202 ,H294469 ,H294531 ,H294600 ,H294663 ,H294729 ,H294791 ,H294857 ,H294922 ,H294990 ,H295054 ,H295124 ,H295203 ,H294470 ,H294532 ,H294601 ,H294664 ,H294730 ,H294792 ,H294858 ,H294923 ,H294991 ,H295056 ,H295125 ,H295206 ,H294471 ,H294533 ,H294602 ,H294665 ,H294731 ,H294793 ,H294859 ,H294924 ,H294992 ,H295057 ,H295126 ,H295207 ,H294472 ,H294534 ,H294603 ,H294666 ,H294732 ,H294794 ,H294860 ,H294925 ,H294993 ,H295058 ,H295127 ,H295208 ,H294473 ,H294535 ,H294604 ,H294667 ,H294733 ,H294795 ,H294861 ,H294926 ,H294995 ,H295059 ,H295128 ,H295209 ,H294474 ,H294536 ,H294605 ,H294668 ,H294734 ,H294796 ,H294862 ,H294927 ,H294996 ,H295060 ,H295129 ,H295210 ,H294475 ,H294537 ,H294606 ,H294669 ,H294735 ,H294797 ,H294863 ,H294928 ,H294997 ,H295061 ,H295130 ,H295211 ,H294476 ,H294538 ,H294607 ,H294670 ,H294736 ,H294798 ,H294864 ,H294929 ,H294998 ,H295062 ,H295131 ,H295212 ,H294477 ,H294539 ,H294608 ,H294671 ,H294737 ,H294799 ,H294865 ,H294930 ,H294999 ,H295063 ,H295132 ,H295213 ,H294478 ,H294540 ,H294610 ,H294672 ,H294738 ,H294800 ,H294866 ,H294931 ,H295000 ,H295064 ,H295133 ,H295214 ,H294479 ,H294541 ,H294611 ,H294673 ,H294739 ,H294801 ,H294867 ,H294932 ,H295001 ,H295065 ,H295134 ,H295216 ,H294480 ,H294542 ,H294612 ,H294674 ,H294740 ,H294802 ,H294868 ,H294933 ,H295002 ,H295066 ,H295135 ,H295217 ,H294481 ,H294543 ,H294613 ,H294675 ,H294741 ,H294803 ,H294869 ,H294934 ,H295003 ,H295067 ,H295136 ,H295221 ,H294482 ,H294544 ,H294614 ,H294676 ,H294742 ,H294804 ,H294870 ,H294935 ,H295004 ,H295068 ,H295138 ,H295223 ,H294483 ,H294545 ,H294615 ,H294677 ,H294743 ,H294806 ,H294871 ,H294936 ,H295005 ,H295069 ,H295139 ,H295224 ,H294484 ,H294546 ,H294616 ,H294678 ,H294744 ,H294807 ,H294872 ,H294937 ,H295006 ,H295070 ,H295140 ,H295225 ,H294485 ,H294547 ,H294617 ,H294679 ,H294745 ,H294808 ,H294874 ,H294938 ,H295007 ,H295071 ,H295141 ,H295226 ,H294486 ,H294548 ,H294618 ,H294680 ,H294746 ,H294809 ,H294875 ,H294940 ,H295008 ,H295072 ,H295142 ,H295227 ,H294487 ,H294549 ,H294619 ,H294681 ,H294747 ,H294810 ,H294876 ,H294941 ,H295009 ,H295073 ,H295143 ,H295228 ,H294488 ,H294550 ,H294620 ,H294682 ,H294748 ,H294811 ,H294877 ,H294942 ,H295010 ,H295074 ,H295144 ,H295229 ,H294489 ,H294551 ,H294621 ,H294683 ,H294749 ,H294812 ,H294878 ,H294943 ,H295011 ,H295075 ,H295145 ,H295231 ,H294490 ,H294552 ,H294622 ,H294684 ,H294750 ,H294813 ,H294879 ,H294945 ,H295012 ,H295076 ,H295146 ,H295235 ,H294491 ,H294553 ,H294623 ,H294685 ,H294751 ,H294814 ,H294880 ,H294946 ,H295013 ,H295077 ,H295147 ,H295236 ,H294492 ,H294554 ,H294624 ,H294686 ,H294752 ,H294815 ,H294881 ,H294947 ,H295014 ,H295078 ,H295148 ,H295238 ,H294493 ,H294555 ,H294625 ,H294687 ,H294753 ,H294816 ,H294882 ,H294948 ,H295015 ,H295080 ,H295149 ,H295239 ,H294494 ,H294556 ,H294626 ,H294688 ,H294754 ,H294817 ,H294883 ,H294949 ,H295016 ,H295081 ,H295150 ,H295240 ,H294495 ,H294557 ,H294627 ,H294689 ,H294755 ,H294818 ,H294884 ,H294950 ,H295017 ,H295082 ,H295151 ,H295241 ,H294496 ,H294564 ,H294628 ,H294690 ,H294756 ,H294820 ,H294885 ,H294951 ,H295018 ,H295083 ,H295152 ,H295242 ,H294497 ,H294565 ,H294629 ,H294691 ,H294757 ,H294821 ,H294886 ,H294952 ,H295019 ,H295084 ,H295154 ,H295244 ,H294498 ,H294567 ,H294630 ,H294692 ,H294758 ,H294822 ,H294887 ,H294953 ,H295020 ,H295085 ,H295155 ,H295245 ,H294499 ,H294568 ,H294631 ,H294693 ,H294759 ,H294823 ,H294888 ,H294954 ,H295021 ,H295086 ,H295156 ,H295246 ,H294500 ,H294569 ,H294632 ,H294694 ,H294760 ,H294824 ,H294889 ,H294955 ,H295022 ,H295087 ,H295157 ,H295247 ,H294501 ,H294570 ,H294633 ,H294695 ,H294761 ,H294825 ,H294890 ,H294956 ,H295023 ,H295089 ,H295158 ,H295248 ,H294502 ,H294571 ,H294634 ,H294696 ,H294762 ,H294826 ,H294891 ,H294957 ,H295024 ,H295090 ,H295159 ,H295249 ,H294503 ,H294572 ,H294635 ,H294697 ,H294763 ,H294827 ,H294892 ,H294958 ,H295025 ,H295091 ,H295160 ,H295250 ,H294504 ,H294573 ,H294636 ,H294698 ,H294764 ,H294828 ,H294893 ,H294959 ,H295026 ,H295093 ,H295161 ,H295252 ,H294505 ,H294574 ,H294637 ,H294699 ,H294765 ,H294829 ,H294894 ,H294960 ,H295027 ,H295094 ,H295162 ,H295254 ,H294506 ,H294575 ,H294638 ,H294700 ,H294766 ,H294830 ,H294895 ,H294961 ,H295028 ,H295095 ,H295163 ,H295255 ,H294507 ,H294576 ,H294639 ,H294701 ,H294767 ,H294831 ,H294896 ,H294962 ,H295029 ,H295096 ,H295169 ,H295265;
 
2) H140002 H140087 H180135 H180273 H180463 H180554 H180623 H180685 H180747 H180809 H180868 H181026 H181085 H140003 H140089 H180143 H180274 H180466 H180555 H180624 ,H180686 ,H180748 ,H180810 ,H180869 H181027 H181086 H140004 H140091 ,H180144 ,H180275 ,H180467 ,H180556 H180625 H180687 H180749 H180811 ,H180870 ,H181028 ,H181087 ,H140005 H140093 H180148 H180283 H180469 ,H180559 ,H180626 ,H180688 ,H180750 H180812 H180871 H181029 H181088 ,H140006 ,H140094 ,H180157 ,H180287 H180470 H180560 H180627 H180689 ,H180751 ,H180813 ,H180872 ,H181030 H181089 H140007 H140095 H180159 ,H180290 ,H180471 ,H180561 ,H180628 H180690 H180752 H180814 H180873 ,H181031 ,H181090 ,H140008 ,H140099 H180161 H180291 H180472 H180562 ,H180629 ,H180691 ,H180753 ,H180815 H180874 H181032 H181091 H140009 ,H140100 ,H180166 ,H180292 ,H180473 H180564 H180630 H180692 H180754 ,H180816 ,H180875 ,H181033 ,H181092 H140010 H140102 H180167 H180293 ,H180474 ,H180566 ,H180631 ,H180694 H180755 H180817 H180876 H181034 ,H181093 ,H140012 ,H140103 ,H180171 H180294 H180475 H180568 H180632 ,H180695 ,H180756 ,H180818 ,H180877 H181035 H181094 H140014 H140105 ,H180175 ,H180295 ,H180476 ,H180569 H180633 H180696 H180757 H180819 ,H180878 ,H181036 ,H181095 ,H140015 H140106 H180178 H180296 H180477 ,H180570 ,H180634 ,H180697 ,H180758 H180820 H180879 H181037 H181096 ,H140016 ,H140108 ,H180179 ,H180298 H180478 H180572 H180635 H180698 ,H180759 ,H180821 ,H180880 ,H181038 H181097 H140017 H180328 H180493 ,H180584 ,H180645 ,H180708 ,H180769 ,H180831 H180891 H181048 H181107 ,H140034 ,H180004 ,H180208 ,H180329 ,H180494 H180585 H180646 H180709 ,H180770 ,H180832 ,H180892 ,H181049 ,H181108 H140035 H180007 H180209 ,H180404 ,H180498 ,H180587 ,H180647 ,H180710 H180771 H180833 H180894 ,H181050 ,H181109 ,H140036 ,H180008 ,H180210 H180405 H180499 H180588 ,H180649 ,H180711 ,H180772 ,H180834 ,H180895 H181051 H181110 H140037 ,H180016 ,H180214 ,H180406 ,H180501 ,H180589 H180650 H180713 H180773 ,H180835 ,H180896 ,H181052 ,H181111 ,H140040 H180019 H180215 H180407 ,H180507 ,H180590 ,H180651 ,H180714 ,H180774 H180836 H180897 H181053 ,H181112 ,H140041 ,H180025 ,H180217 ,H180409 H180509 H180591 H180652 ,H180715 ,H180775 ,H180837 ,H180898 ,H181055 H181113 H140042 H180028 ,H180218 ,H180411 ,H180510 ,H180592 ,H180653 H180716 H180776 H180838 ,H180899 ,H181056 ,H181114 ,H140044 ,H180040 H180220 H180412 H180511 ,H180593 ,H180654 ,H180717 ,H180777 ,H180839 H180901 H181057 H181115 ,H140049 ,H180043 ,H180221 ,H180414 ,H180514 H180594 H180655 H180718 ,H180778 ,H180840 ,H180907 ,H181058 ,H181116 H140050 H180044 H180222 ,H180417 ,H180515 ,H180595 ,H180656 ,H180719 H180779 H180841 H181000 ,H181059 ,H181117 ,H140051 ,H180048 ,H180225 H180420 H180517 H180596 ,H180657 ,H180720 ,H180780 ,H180842 ,H181001 H181060 H181118 H140052 ,H180049 ,H180226 ,H180424 ,H180518 ,H180597 H180658 H180721 H180781 ,H180843 ,H181002 ,H181061 ,H181119 ,H140053 H180050 H180228 H180425 ,H180519 ,H180598 ,H180659 ,H180722 ,H180782 H180844 H181003 H181062 ,H181120 ,H140054 ,H180052 ,H180229 ,H180426 H180520 H180599 H180660 ,H180723 ,H180783 ,H180845 ,H181004 ,H181063 H181121 H140055 H180056 ,H180233 ,H180427 ,H180521 ,H180600 ,H180661 H180724 H180784 H180847 ,H181005 ,H181064 ,H181123 ,H140056 ,H180058 H180235 H180433 H180522 ,H180601 ,H180662 ,H180725 ,H180785 ,H180848 H181006 H181065 H181124 ,H140057 ,H180059 ,H180236 ,H180434 ,H180527 H180602 H180663 H180726 ,H180786 ,H180849 ,H181007 ,H181066 ,H181125 H140059 H180065 H180237 ,H180437 ,H180528 ,H180603 ,H180664 ,H180727 H180788 H180850 H181008 ,H181067 ,H181126 ,H140060 ,H180066 ,H180238 H180440 H180529 H180604 ,H180665 ,H180729 ,H180789 ,H180851 ,H181009 H181068 H181127 H140061 ,H180073 ,H180240 ,H180441 ,H180532 ,H180605 H180667 H180730 H180791 ,H180852 ,H181010 ,H181069 ,H181128 ,H140063 H180080 H180242 H180442 ,H180533 ,H180606 ,H180669 ,H180731 ,H180792 H180853 H181011 H181070 ,H181129 ,H140064 ,H180083 ,H180243 ,H180444 H180534 H180607 H180670 ,H180733 ,H180793 ,H180854 ,H181012 ,H181071 H181130 H140065 H180087 ,H180245 ,H180445 ,H180535 ,H180608 ,H180671 H180734 H180794 H180855 ,H181013 ,H181072 ,H181132 ,H140066 ,H180098 H180249 H180446 H180536 ,H180610 ,H180672 ,H180735 ,H180796 ,H180856 H181014 H181073 H181133 ,H140068 ,H180099 ,H180250 ,H180447 ,H180538 H180611 H180673 H180736 ,H180798 ,H180857 ,H181015 ,H181074 ,H181134 H140069 H180102 H180254 ,H180449 ,H180539 ,H180612 ,H180674 ,H180737 H180799 H180858 H181016 ,H181075 ,H181135 ,H140072 ,H180103 ,H180255 H180450 H180541 H180614 ,H180675 ,H180738 ,H180800 ,H180859 ,H181017 H181076 H181136 H140074 ,H180104 ,H180256 ,H180451 ,H180542 ,H180615 H180676 H180739 H180801 ,H180860 ,H181018 ,H181077 ,H181137 ,H140075 H180107 H180257 H180453 ,H180543 ,H180616 ,H180678 ,H180740 ,H180802 H180861 H181019 H181078 ,H181138 ,H140080 ,H180115 ,H180258 ,H180454 H180544 H180617 H180679 ,H180741 ,H180803 ,H180862 ,H181020 ,H181079 H181139 H140082 H180116 ,H180260 ,H180456 ,H180548 ,H180618 ,H180680 H180742 H180804 H180863 ,H181021 ,H181080 ,H181140 ,H140083 ,H180117 H180262 H180457 H180549 ,H180619 ,H180681 ,H180743 ,H180805 ,H180864 H181022 H181081 H181141 ,H140084 ,H180122 ,H180268 ,H180459 ,H180550 H180620 H180682 H180744 ,H180806 ,H180865 ,H181023 ,H181082 ,H181142 H140085 H180124 H180271 ,H180460 ,H180551 ,H180621 ,H180683 ,H180745 H180807 H180866 H181024 ,H181083 ,H181143 ,H140086 ,H180129 ,H180272 H180462 H180553 H180622 ,H180684 ,H180746 ,H180808 ,H180867 ,H181025 H181084 H181145 H181146 ,H181210 ,H270260 ,H270447 ,H270634 ,H270783 H270894 H271101 H271225 ,H271320 ,H271409 ,H271499 ,H271575 ,H181147 H181211 H270261 H270451 ,H270635 ,H270785 ,H270895 ,H271102 ,H271228 H271322 H271410 H271500 ,H271576 ,H181148 ,H181212 ,H270267 ,H270452 H270639 H270787 H270897 ,H271103 ,H271229 ,H271325 ,H271411 ,H271501 H271577 H181149 H181214 ,H270271 ,H270454 ,H270641 ,H270789 ,H270898 H271104 H271231 H271327 ,H271412 ,H271503 ,H271578 ,H181150 ,H181215 H270273 H270455 H270644 ,H270793 ,H270899 ,H271107 ,H271233 ,H271328 H271415 H271504 H271580 ,H181151 ,H181218 ,H270277 ,H270458 ,H270645 H270796 H271000 H271108 ,H271234 ,H271329 ,H271416 ,H271505 ,H271581 H181152 H181220 H270280 ,H270461 ,H270646 ,H270800 ,H271002 ,H271109 H271235 H271330 H271417 ,H271506 ,H271583 ,H181153 ,H181222 ,H270281 H270462 H270647 H270801 ,H271004 ,H271110 ,H271236 ,H271331 ,H271419 H271508 H271584 H181154 ,H181223 ,H270282 ,H270464 ,H270649 ,H270803 H271005 H271111 H271238 ,H271332 ,H271421 ,H271509 ,H271586 ,H181155 H181224 H270285 H270466 ,H270651 ,H270804 ,H271009 ,H271113 ,H271239 H271333 H271422 H271510 ,H271589 ,H181156 ,H181225 ,H270290 ,H270470 H270652 H270805 H271013 ,H271114 ,H271241 ,H271336 ,H271423 ,H271511 H271590 H181157 H181228 ,H270297 ,H270473 ,H270653 ,H270806 ,H271015 H271115 H271245 H271337 ,H271424 ,H271512 ,H271591 ,H181158 ,H181230 H270302 H270474 H270654 ,H270812 ,H271016 ,H271116 ,H271247 ,H271338 H271426 H271513 H271592 ,H181159 ,H189999 ,H270303 ,H270476 ,H270656 H270813 H271017 H271120 ,H271248 ,H271339 ,H271428 ,H271514 ,H271595 H181160 H260916 H270307 ,H270477 ,H270660 ,H270817 ,H271019 ,H271121 H271250 H271340 H271430 ,H271516 ,H271596 ,H181161 ,H260917 ,H270310 H270479 H270661 H270820 ,H271020 ,H271127 ,H271251 ,H271342 ,H271431 H271517 H271597 H181162 ,H260923 ,H270314 ,H270482 ,H270662 ,H270821 H271021 H271132 H271256 ,H271344 ,H271434 ,H271518 ,H271598 ,H181163 H260926 H270323 H270483 ,H270664 ,H270822 ,H271023 ,H271135 ,H271257 H271345 H271435 H271520 ,H271599 ,H181164 ,H260932 ,H270324 ,H270486 H270665 H270823 H271024 ,H271137 ,H271259 ,H271347 ,H271436 ,H271521 H271600 H181165 H260938 ,H270332 ,H270487 ,H270667 ,H270825 ,H271025 H271141 H271260 H271349 ,H271437 ,H271522 ,H271601 ,H181166 ,H260939 H270335 H270489 H270669 ,H270826 ,H271026 ,H271142 ,H271263 ,H271350 H271441 H271525 H271603 ,H181167 ,H260944 ,H270338 ,H270490 ,H270670 H270827 H271029 H271143 ,H271264 ,H271351 ,H271442 ,H271527 ,H271604 H181168 H260947 H270341 ,H270491 ,H270675 ,H270828 ,H271031 ,H271144 H271266 H271355 H271444 ,H271528 ,H271605 ,H181170 ,H270010 ,H270344 H270495 H270681 H270829 ,H271032 ,H271145 ,H271267 ,H271356 ,H271445 H271529 H271606 H181171 ,H270021 ,H270345 ,H270498 ,H270682 ,H270833 H271034 H271149 H271269 ,H271357 ,H271447 ,H271530 ,H271608 ,H181172 H270026 H270351 H270499 ,H270684 ,H270836 ,H271035 ,H271151 ,H271270 H271358 H271448 H271532 ,H271609 ,H181173 ,H270027 ,H270352 ,H270500 H270686 H270837 H271037 ,H271152 ,H271272 ,H271359 ,H271449 ,H271533 H271610 H181174 H270029 ,H270353 ,H270501 ,H270690 ,H270838 ,H271038 H271154 H271273 H271360 ,H271450 ,H271535 ,H271611 ,H181175 ,H270030 H270356 H270502 H270692 ,H270840 ,H271039 ,H271155 ,H271274 ,H271361 H271451 H271536 H271612 ,H181176 ,H270038 ,H270360 ,H270503 ,H270693 H270842 H271042 H271161 ,H271276 ,H271363 ,H271453 ,H271537 ,H271613 H181177 H270045 H270364 ,H270504 ,H270698 ,H270844 ,H271043 ,H271166 H271280 H271364 H271454 ,H271538 ,H271614 ,H181178 ,H270047 ,H270370 H270505 H270699 H270846 ,H271044 ,H271172 ,H271281 ,H271365 ,H271456 H271539 H271615 H181179 ,H270073 ,H270371 ,H270511 ,H270700 ,H270852 H271051 H271178 H271282 ,H271366 ,H271457 ,H271540 ,H271616 ,H181180 H270079 H270373 H270512 ,H270705 ,H270854 ,H271052 ,H271182 ,H271283 H271367 H271458 H271541 ,H271617 ,H181181 ,H270088 ,H270378 ,H270513 H270708 H270857 H271055 ,H271183 ,H271284 ,H271368 ,H271459 ,H271542 H271619 H181182 H270096 ,H270383 ,H270516 ,H270710 ,H270858 ,H271056 H271184 H271285 H271369 ,H271461 ,H271543 ,H271620 ,H181183 ,H270101 H270384 H270518 H270714 ,H270859 ,H271059 ,H271185 ,H271287 ,H271371 H271462 H271544 H271621 ,H181184 ,H270106 ,H270385 ,H270520 ,H270716 H270861 H271061 H271189 ,H271289 ,H271372 ,H271464 ,H271545 ,H271622 H181185 H270110 H270386 ,H270522 ,H270718 ,H270863 ,H271062 ,H271190 H271290 H271374 H271465 ,H271546 ,H271627 ,H181187 ,H270111 ,H270391 H270525 H270719 H270864 ,H271063 ,H271191 ,H271291 ,H271375 ,H271466 H271547 H271629 H181188 ,H270118 ,H270392 ,H270526 ,H270725 ,H270865 H271067 H271192 H271292 ,H271376 ,H271467 ,H271548 ,H271630 ,H181189 H270126 H270395 H270529 ,H270726 ,H270866 ,H271068 ,H271193 ,H271294 H271377 H271468 H271550 ,H271631 ,H181190 ,H270134 ,H270398 ,H270532 H270727 H270867 H271071 ,H271195 ,H271295 ,H271379 ,H271470 ,H271551 H271632 H181191 H270138 ,H270399 ,H270535 ,H270728 ,H270868 ,H271072 H271197 H271296 H271380 ,H271472 ,H271552 ,H271633 ,H181192 ,H270201 H270401 H270539 H270732 ,H270869 ,H271073 ,H271198 ,H271297 ,H271381 H271473 H271553 H271634 ,H181193 ,H270209 ,H270410 ,H270540 ,H270733 H270871 H271075 H271199 ,H271298 ,H271382 ,H271474 ,H271554 ,H271636 H181194 H270211 H270416 ,H270542 ,H270735 ,H270872 ,H271076 ,H271200 H271299 H271383 H271475 ,H271555 ,H271637 ,H181195 ,H270215 ,H270418 H270544 H270737 H270873 ,H271080 ,H271201 ,H271300 ,H271384 ,H271476 H271557 H271638 H181196 ,H270216 ,H270419 ,H270550 ,H270739 ,H270875 H271082 H271204 H271302 ,H271386 ,H271477 ,H271558 ,H271639 ,H181197 H270219 H270421 H270601 ,H270746 ,H270877 ,H271083 ,H271205 ,H271303 H271387 H271478 H271561 ,H271641 ,H181198 ,H270227 ,H270425 ,H270602 H270749 H270878 H271085 ,H271207 ,H271304 ,H271388 ,H271479 ,H271562 H271642 H181199 H270228 ,H270426 ,H270606 ,H270751 ,H270879 ,H271086 H271208 H271305 H271389 ,H271481 ,H271563 ,H271643 ,H181200 ,H270229 H270427 H270607 H270752 ,H270880 ,H271088 ,H271209 ,H271306 ,H271390 H271483 H271564 H271645 ,H181201 ,H270230 ,H270428 ,H270613 ,H270755 H270882 H271091 H271210 ,H271307 ,H271392 ,H271484 ,H271565 ,H271646 H181202 H270232 H270430 ,H270615 ,H270757 ,H270883 ,H271092 ,H271211 H271309 H271395 H271485 ,H271566 ,H271647 ,H181203 ,H270235 ,H270431 H270622 H270761 H270884 ,H271093 ,H271212 ,H271312 ,H271398 ,H271487 H271567 H271648 H181204 ,H270244 ,H270435 ,H270623 ,H270762 ,H270885 H271094 H271216 H271314 ,H271399 ,H271488 ,H271568 ,H271649 ,H181205 H270245 H270437 H270624 ,H270763 ,H270886 ,H271095 ,H271217 ,H271315 H271401 H271492 H271570 ,H271650 ,H181206 ,H270251 ,H270438 ,H270625 H270766 H270888 H271097 ,H271218 ,H271316 ,H271402 ,H271493 ,H271571 H271651 H181207 H270252 ,H270439 ,H270627 ,H270777 ,H270889 ,H271098 H271222 H271317 H271403 ,H271494 ,H271572 ,H271652 ,H181208 ,H270255 H270443 H270631 H270781 ,H270891 ,H271099 ,H271223 ,H271318 ,H271404 H271495 H271573 H271653 ,H181209 ,H270256 ,H270446 ,H270632 ,H270782 H270892 H271100 H271224 ,H271319 ,H271406 ,H271498 ,H271574 ,H271654 H271655 ,H271739 H271816 ,H271901 ,H271983 ,H272071 ,H272149 ,H272251 H272348 H272447 H272865 ,H272957 ,H273062 ,H271656 ,H271740 ,H271817 H271902 H271984 H272072 ,H272150 ,H272253 ,H272350 ,H272448 ,H272867 H272958 H273067 H271657 ,H271741 ,H271818 ,H271904 ,H271985 ,H272073 H272151 H272254 H272351 ,H272449 ,H272869 ,H272959 ,H273068 ,H271658 H271743 H271819 H271907 ,H271986 ,H272074 ,H272152 ,H272255 ,H272352 H272450 H272870 H272962 ,H273069 ,H271659 ,H271744 ,H271820 ,H271908 H271987 H272075 H272154 ,H272256 ,H272353 ,H272451 ,H272871 ,H272965 H273070 H271660 H271746 ,H271821 ,H271909 ,H271988 ,H272076 ,H272160 H272257 H272356 H272452 ,H272875 ,H272966 ,H273071 ,H271666 ,H271747 H271822 H271910 H271989 ,H272077 ,H272161 ,H272258 ,H272357 ,H272453 H272877 H272967 H273074 ,H271667 ,H271748 ,H271823 ,H271911 ,H271990 H272079 H272164 H272261 ,H272358 ,H272455 ,H272878 ,H272969 ,H273078 H271670 H271749 H271824 ,H271912 ,H271991 ,H272080 ,H272165 ,H272262 H272361 H272457 H272879 ,H272970 ,H273079 ,H271671 ,H271750 ,H271826 H271913 H271992 H272082 ,H272166 ,H272263 ,H272363 ,H272459 ,H272880 H272972 H273081 H271672 ,H271751 ,H271827 ,H271914 ,H271996 ,H272083 H272167 H272264 H272364 ,H272461 ,H272881 ,H272974 ,H273085 ,H271673 H271752 H271828 H271915 ,H271997 ,H272084 ,H272170 ,H272265 ,H272366 H272463 H272882 H272975 ,H273087 ,H271674 ,H271753 ,H271829 ,H271916 H271998 H272087 H272171 ,H272266 ,H272367 ,H272465 ,H272883 ,H272976 H273090 H271675 H271754 ,H271830 ,H271917 ,H271999 ,H272088 ,H272175 H272268 H272368 H272467 ,H272884 ,H272977 ,H273091 ,H271676 ,H271756 H271832 H271919 H272002 ,H272090 ,H272176 ,H272269 ,H272369 ,H272468 H272886 H272979 H273094 ,H271677 ,H271757 ,H271834 ,H271920 ,H272004 H272091 H272177 H272270 ,H272371 ,H272471 ,H272887 ,H272980 ,H273095 H271679 H271758 H271836 ,H271922 ,H272005 ,H272092 ,H272181 ,H272272 H272373 H272472 H272888 ,H272983 ,H273097 ,H271680 ,H271759 ,H271837 H271923 H272006 H272093 ,H272182 ,H272273 ,H272374 ,H272475 ,H272891 H272984 H273098 H271682 ,H271761 ,H271839 ,H271924 ,H272007 ,H272094 H272183 H272274 H272375 ,H272477 ,H272892 ,H272988 ,H273099 ,H271683 H271764 H271840 H271925 ,H272010 ,H272095 ,H272185 ,H272276 ,H272376 H272478 H272894 H272989 ,H290001 ,H271684 ,H271765 ,H271841 ,H271927 H272011 H272096 H272186 ,H272278 ,H272378 ,H272482 ,H272895 ,H272991 H290003 H271685 H271766 ,H271842 ,H271928 ,H272012 ,H272097 ,H272189 H272279 H272379 H272483 ,H272896 ,H272992 ,H290004 ,H271686 ,H271768 H271843 ,H271929 H272013 ,H272098 ,H272190 ,H272280 ,H272382 ,H272484 H272897 H272994 H290014 ,H271687 ,H271769 ,H271844 ,H271930 ,H272015 H272099 H272191 H272281 ,H272383 ,H272485 ,H272898 ,H272995 ,H290026 H271688 H271770 H271846 ,H271932 ,H272017 ,H272100 ,H272192 ,H272282 H272384 H272489 H272900 ,H272997 ,H290030 ,H271689 ,H271771 ,H271847 H271933 H272018 H272101 ,H272193 ,H272284 ,H272385 ,H272490 ,H272901 H272998 H290031 H271692 ,H271772 ,H271848 ,H271934 ,H272019 ,H272102 H272194 H272285 H272386 ,H272493 ,H272902 ,H273000 ,H290032 ,H271695 H271774 H271849 H271936 ,H272020 ,H272103 ,H272196 ,H272286 ,H272387 H272495 H272903 H273001 ,H290033 ,H271696 ,H271775 ,H271850 ,H271937 H272021 H272104 H272198 ,H272287 ,H272389 ,H272496 ,H272904 ,H273002 H290034 H271697 H271776 ,H271851 ,H271938 ,H272022 ,H272106 ,H272199 H272288 H272390 H272800 ,H272906 ,H273005 ,H290104 ,H271698 ,H271777 H271852 H271939 H272024 ,H272107 ,H272200 ,H272289 ,H272391 ,H272802 H272907 H273007 H290105 ,H271699 ,H271778 ,H271854 ,H271940 ,H272025 H272108 H272201 H272292 ,H272392 ,H272807 ,H272913 ,H273008 ,H290109 H271700 H271779 H271855 ,H271943 ,H272026 ,H272109 ,H272205 ,H272294 H272393 H272808 H272915 ,H273010 ,H290110 ,H271701 ,H271781 ,H271857 H271944 H272027 H272110 ,H272206 ,H272295 ,H272395 ,H272809 ,H272916 H273012 H290111 H271702 ,H271782 ,H271859 ,H271945 ,H272028 ,H272112 H272207 H272296 H272396 ,H272810 ,H272917 ,H273013 ,H290113 H271703 H271784 H271861 H271946 ,H272030 ,H272113 ,H272208 ,H272297 H272398 H272812 H272918 H273014 ,H290114 ,H271704 ,H271786 ,H271863 ,H271947 H272032 H272114 H272210 ,H272298 ,H272399 ,H272813 ,H272919 ,H273017 H290116 H271705 H271787 ,H271864 ,H271948 ,H272034 ,H272116 ,H272211 H272300 H272400 H272814 ,H272920 ,H273018 ,H290118 ,H271706 ,H271788 H271865 H271949 H272036 ,H272117 ,H272212 ,H272303 ,H272402 ,H272815 H272921 H273019 H290121 ,H271707 ,H271789 ,H271867 ,H271950 ,H272038 H272119 H272213 H272304 ,H272403 ,H272817 ,H272923 ,H273020 ,H290122 H271708 H271790 H271868 ,H271952 ,H272039 ,H272121 ,H272215 ,H272305 H272404 H272818 H272924 ,H273021 ,H290123 ,H271709 ,H271791 ,H271869 H271953 H272040 H272122 ,H272217 ,H272308 ,H272406 ,H272819 ,H272925 H273022 H290125 H271710 ,H271792 ,H271871 ,H271955 ,H272041 ,H272123 H272218 H272312 H272408 ,H272821 ,H272927 ,H273023 ,H290128 ,H271715 H271793 H271873 H271956 ,H272046 ,H272124 ,H272221 ,H272314 ,H272409 H272823 H272928 H273024 ,H290130 ,H271716 ,H271794 ,H271874 ,H271957 H272047 ,H272125 H272222 ,H272315 ,H272411 ,H272829 ,H272929 ,H273025 H290132 ,H271717 H271795 ,H271876 ,H271958 ,H272048 ,H272126 ,H272224 H272316 ,H272414 H272830 ,H272930 ,H273028 ,H290135 ,H271718 ,H271796 H271878 ,H271959 H272051 ,H272127 ,H272227 ,H272317 ,H272415 ,H272831 H272931 ,H273033 H290137 ,H271719 ,H271798 ,H271880 ,H271960 ,H272053 H272128 ,H272228 H272319 ,H272417 ,H272833 ,H272934 ,H273034 ,H290138 H271722 ,H271799 H271882 ,H271962 ,H272054 ,H272130 ,H272229 ,H272320 H272419 ,H272836 H272935 ,H273037 ,H290139 ,H271723 ,H271800 ,H271883 H271963 ,H272055 H272131 ,H272230 ,H272322 ,H272420 ,H272838 ,H272937 H273038 ,H290141 H271725 ,H271803 ,H271884 ,H271965 ,H272056 ,H272132 H272232 ,H272323 H272424 ,H272839 ,H272939 ,H273043 ,H290145 ,H271726 H271804 ,H271885 H271967 ,H272057 ,H272133 ,H272233 ,H272330 ,H272429 H272840 ,H272940 H273044 ,H290151 ,H271727 ,H271805 ,H271886 ,H271968 H272058 ,H272135 H272234 ,H272331 ,H272430 ,H272843 ,H272942 ,H273045 H290152 ,H271728 H271806 ,H271887 ,H271969 ,H272059 ,H272139 ,H272238 H272332 ,H272431 H272844 ,H272943 ,H273046 ,H290154 ,H271731 ,H271807 H271888 ,H271970 H272060 ,H272140 ,H272241 ,H272334 ,H272433 ,H272845 H272944 ,H273047 H290155 ,H271732 ,H271808 ,H271889 ,H271971 ,H272061 H272141 ,H272242 H272335 ,H272435 ,H272850 ,H272947 ,H273050 ,H290156 H271733 ,H271809 H271891 ,H271977 ,H272063 ,H272142 ,H272244 ,H272337 H272436 ,H272851 H272948 ,H273051 ,H290157 ,H271734 ,H271810 ,H271892 H271978 ,H272065 H272144 ,H272245 ,H272338 ,H272437 ,H272852 ,H272949 H273054 ,H290158 H271735 ,H271812 ,H271894 ,H271979 ,H272066 ,H272145 H272246 ,H272340 H272439 ,H272853 ,H272950 ,H273058 ,H290159 ,H271736 H271813 ,H271897 H271980 ,H272067 ,H272146 ,H272247 ,H272342 ,H272441 H272855 ,H272952 H273059 ,H290160 ,H271737 ,H271814 ,H271898 ,H271981 H272068 ,H272147 H272248 ,H272344 ,H272442 ,H272861 ,H272954 ,H273060 H290161 ,H271738 H271815 ,H271899 ,H271982 ,H272070 ,H272148 ,H272249 H272347 ,H272443 H272863 ,H272955 ,H273061 ,H290162 ,H290164 ,H290280 H290357 ,H290531 H290165 ,H290281 ,H290359 ,H290532 ,H290166 ,H290283 H290360 ,H290534 H290168 ,H290284 ,H290363 ,H290535 ,H290173 ,H290285 H290364 ,H290536 H290175 ,H290286 ,H290365 ,H290537 ,H290176 ,H290288 H290366 ,H290539 H290181 ,H290289 ,H290367 ,H290542 ,H290182 ,H290290 H290368 ,H290543 H290185 ,H290291 ,H290369 ,H290544 ,H290187 ,H290292 H290370 ,H290545 H290189 ,H290293 ,H290373 ,H290546 ,H290191 ,H290296 H290374 ,H292832 H290193 ,H290297 ,H290377 ,H290194 ,H290299 ,H290378 H290195 ,H290301 H290380 ,H290196 ,H290302 ,H290382 ,H290197 ,H290305 H290383 ,H290198 H290306 ,H290384 ,H290203 ,H290307 ,H290385 ,H290206 H290309 ,H290387 H290209 ,H290310 ,H290388 ,H290210 ,H290311 ,H290389 H290211 ,H290312 H290390 ,H290212 ,H290314 ,H290393 ,H290213 ,H290315 H290394 ,H290214 H290316 ,H290395 ,H290215 ,H290318 ,H290396 ,H290216 H290319 ,H290398 H290217 ,H290320 ,H290404 ,H290219 ,H290322 ,H290406 H290220 ,H290323 H290408 ,H290223 ,H290324 ,H290409 ,H290225 ,H290325 H290410 ,H290226 H290327 ,H290411 ,H290227 ,H290328 ,H290412 ,H290229 H290329 ,H290413 H290231 ,H290330 ,H290415 ,H290235 ,H290331 ,H290416 H290236 ,H290332 H290417 ,H290237 ,H290333 ,H290424 ,H290239 ,H290334 H290425 ,H290240 H290335 ,H290426 ,H290242 ,H290336 ,H290427 ,H290244 H290337 ,H290500 H290246 ,H290338 ,H290502 ,H290247 ,H290339 ,H290506 H290250 ,H290340 H290507 ,H290255 ,H290342 ,H290513 ,H290257 ,H290343 H290514 ,H290258 H290344 ,H290515 ,H290259 ,H290345 ,H290516 ,H290260 H290346 ,H290518 H290261 ,H290347 ,H290521 ,H290264 ,H290348 ,H290522 H290265 H290349 H290523 ,H290266 ,H290350 ,H290524 ,H290268 ,H290351 H290525 ,H290269 H290353 H290526 H290271 H290354 H290527 H290275 H290355 H290528 H290279 H290356 H290529
RECALLING FIRM/MANUFACTURER Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, 
REASON An event has been reported to Varian which entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator.
VOLUME OF PRODUCT IN COMMERCE 5714 units
DISTRIBUTION Nationwide and Internationally

 

PRODUCT
1) LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO. Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics, and tissue bundles.
 
2) LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider, LS1520, Sterile EO. Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics, and tissue bundles. 
CODE
1) Lot numbers: S1CB001, S1CB002, S1CB003, S1CB004, S1CB005, S1CB006, S1CB007R, S1CB008X, S1CB009X, S1CB012RX, S1CB013PRX, S1CB014PRX, S1CB015PRX, S1CB016PRX, S1CB017PRX, S1CB018PRX, S1CB019PRX, S1CB020PRX, S1CB021PRX, S1CB022PRX, S1CB023PRX, S1CB024PRX, S1CB025PRX, S1DB006X, S1DB007X, S1DB008X, S1DB009X, S1DB010X, S1DB011X, S1DB012X, S1DB013X, S1DB014X, S1DB015X, S1DB016X, S1DB017X, S1DB018X, S1DB019X, S1DB020X, S1DB021X, S1DB022X, S1DB023X, S1EB001X, S1EB002X, S1EB003X, S1EB004X, S1EB005X, S1EB006X, S1EB007RX, S1EB008RX, S1EB009X, S1EB010RX, S1EB011RX, S1EB016P, S1EB017P, S1EB018P, S1EB019P, S1EB020P, S1EB021P, S1EB022P, S1EB023P, S1EB024P, S1EB025P, S1EB026P, S1EB027P, S1EB028P, S1EB029P, S1EB030P, S1EB031P, S1EB032P, S1EB033P, S1EB034P, S1EB035P, S1EB036P, S1EB037P, S1EB038P, S1EB039P, S1EB040P, S1EB041P, S1EB042P, S1FB001P, S1FB005PX, S1FB006PX, S1FB007PX, S1FB008PX, S1FB009PX, S1FB010PX, S1FB011PX, S1FB012PX, S1FB013PX, S1FB014PX, S1FB015PX, S1FB016PX, S1FB017PX, S1FB027PX, S1FB028PX, S1FB029PX, S1FB040X, S1FB041X, S1fb042X, S1FB043X, S1FB044X, S1FB045X, S1FB046X, S1FB047X, S1FB048X, S1FB052X, S1GB001X, S1GB002X, S1GB003x, S1GB004X, S1GB009X, S1GB010X, S1GB011X, S1GB012X, S1GB013X, S1GB014X, S1GB015X, S1GB016X, S1GB017X, S1GB018X, S1HB002, S1HB003, S1HN004, S1HB005, S1HB006, S1HB007, S1HB008, S1HB009P, S1HB014P, S1HB015P, S1HB016P, S1HB017P, S1HB018P, S1HB019, S1HB021X, S1HB022X, S1HB023X, S1HB024X, S1HB027PX, S1HB028PX, S1HB029PX, S1HB031X, S1HB032X, S1HB033X, S1JB034X, S1JB035X, S1JB036X, S1JB038PX, S1JB041X, S1JB042X, S1JB043X, S1JB044PX, S1JB045PX, S1JB046X, S1JB047X, S1JB048X;
 
2) Lot numbers: S1CB010X, S1CB011X, S1DB001X, S1DB002X, S1EB012P, S1EB013P, S1EB014P, S1FB031PX, S1FB032PX, S1FB033PX, S1FB035X, S1FB036X, S1FB037X, S1FB038X, S1FB039X, S1FB049X, S1FB050X, S1FB051X, S1GB005X, S1GB006X, S1GB007X, S1HB010, S1HB011, S1HB012, S1HB013P. S1CB001, S1CB002, S1CB003, S1CB004, S1CB005, S1CB006, S1CB007R, S1CB008X, S1CB009X, S1CB012RX, S1CB013PRX, S1CB014PRX, S1CB015PRX, S1CB016PRX, S1CB017PRX, S1CB018PRX, S1CB019PRX, S1CB020PRX, S1CB021PRX, S1CB022PRX, S1CB023PRX, S1CB024PRX, S1CB025PRX, S1DB006X, S1DB007X, S1DB008X, S1DB009X, S1DB010X, S1DB011X, S1DB012X, S1DB013X, S1DB014X, S1DB015X, S1DB016X, S1DB017X, S1DB018X, S1DB019X, S1DB020X, S1DB021X, S1DB022X, S1DB023X, S1EB001X, S1EB002X, S1EB003X, S1EB004X, S1EB005X, S1EB006X, S1EB007RX, S1EB008RX, S1EB009X, S1EB010RX, S1EB011RX, S1EB016P, S1EB017P, S1EB018P, S1EB019P, S1EB020P, S1EB021P, S1EB022P, S1EB023P, S1EB024P, S1EB025P, S1EB026P, S1EB027P, S1EB028P, S1EB029P, S1EB030P, S1EB031P, S1EB032P, S1EB033P, S1EB034P, S1EB035P, S1EB036P, S1EB037P, S1EB038P, S1EB039P, S1EB040P, S1EB041P, S1EB042P, S1FB001P, S1FB005PX, S1FB006PX, S1FB007PX, S1FB008PX, S1FB009PX, S1FB010PX, S1FB011PX, S1FB012PX, S1FB013PX, S1FB014PX, S1FB015PX, S1FB016PX, S1FB017PX, S1FB027PX, S1FB028PX, S1FB029PX, S1FB040X, S1FB041X, S1fb042X, S1FB043X, S1FB044X, S1FB045X, S1FB046X, S1FB047X, S1FB048X, S1FB052X, S1GB001X, S1GB002X, S1GB003x, S1GB004X, S1GB009X, S1GB010X, S1GB011X, S1GB012X, S1GB013X, S1GB014X, S1GB015X, S1GB016X, S1GB017X, S1GB018X, S1HB002, S1HB003, S1HN004, S1HB005, S1HB006, S1HB007, S1HB008, S1HB009P, S1HB014P, S1HB015P, S1HB016P, S1HB017P, S1HB018P, S1HB019, S1HB021X, S1HB022X, S1HB023X, S1HB024X, S1HB027PX, S1HB028PX, S1HB029PX, S1HB031X, S1HB032X, S1HB033X, S1JB034X, S1JB035X, S1JB036X, S1JB038PX, S1JB041X, S1JB042X, S1JB043X, S1JB044PX, S1JB045PX, S1JB046X, S1JB047X, S1JB048X
RECALLING FIRM/MANUFACTURER
Recalling Firm: Covidien, PLC, Boulder, CO, 
Manufacturer: Covidien Medical Products (Shanghai) Manufacturing LLC, Shanghai, China. .
REASON Retaining pins in handle assembly may disengage and fall into surgical field or compromise handle unlatching.
VOLUME OF PRODUCT IN COMMERCE 120,810 units
DISTRIBUTION Nationwide and Internationally

 

PRODUCT
1) Neulook Fancy FX is packaged in a small glass bottle with a orange, white, and yellow affixed label with black printing that reads, NeuLook COLOR CONTACT LENSES Distributed by EYEZONE Contents : One Lens, 38% water and 62% Polymacon immersed in saline. Caution : To ensure that your contacts stay comfortable and your vision stay clear, ask your eye-care professional for product instruction. ***DIA. 14.0mm B.C 8.6mm***Rxonly STERILE***FDA 510K Cleared Made in Korea***Power : Plane Color : Blue Angelic The color contact lens colors are: Aqua, blue, blue sapphire, dark gray, dark violet, gray, green, hazel, honey, jade, magic angel, misty blue, misty green, misty hazel, pearl gray, pure hazel, sky blue, sweet gray, turquoise, violet, black out, vein, night, white cat, red cat devil, blue angelic, white out, hot red spider web, psycho, cruller, solid yellow, and blue wheel. prescription contact lens. Barcode on label: Bottle: No barcode, Box: 8 806048 000468. 
 
2) Neulook Deluxe is packaged in a pink soft plastic box with white, black, and rainbow printing that reads, NeuLook COLOR CONTACT LENSES Give yourself a whole new look***Contents : Two sterile color contact lenses(62% Polymacon, 38% Water) Immersed in saline and one lens case. Caution : To ensure that your contacts stay comfortable and your Vision stay clear, a1) sk your eye-care professional for product instruction. Made in Korea Distributed by EYEZONE***1023 FDA 510K CLEARED***STERILE***B.C 8.6mm DIA. 14.0mm***8 806048 000468. The color contact lens colors are: Black out, vein, night, white cat, red cat devil, blue angelic, white out, and hot red. prescription contact lens. Barcode on label: Bottle: No barcode, box: 8 806048 000468.
CODE
1) LOT: BD54 EXP 2014/09, include all lots;
2) LOT. BD53, EXP. 2014/08, include all lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eyezone, Santa Fe Springs, CA, 
Manufacturer: Bescon Co., Ltd., Cheonan-City, Republic Of South Korea. 
REASON Pishon Trading dba Eyezone have distributed soft color lens while on FDA hold and were later found to be misbranded.
VOLUME OF PRODUCT IN COMMERCE 24,628 total pairs
DISTRIBUTION Nationwide

 

PRODUCT Allen C-Flex Head Positioning System non-invasive medical device used to support a patient's head during spine surgery Catalog Numbers: A-70700 and A-70701-2. 
CODE
Units: A128573, A157480, A164957, A165624, A179587, A200505, A200508, A203121, A203123, A203124, A203126, A205717, A205730, A205731, A207969, A207970, A207971, A207973, A208274, A208275, A208277, A208278, A208932, A208933, A208934, A209578, A210915, A210916, A210917, A210919, A210920, A214252, A214253, A214254, A214255, A214256, A214582, A214583, A214584, A215498, A215489, A215499, A215500, A216459, A216460, A216461, A217594, A217595, A217596, A217597, A218945, A219496, A219623, A219624, A220031, A220032, A220033, A220664, A220665, A222121, A222122, A222123, A222394, A223961, A223962, A223963, A223964, A224084, A224085, A224144, A224145, A225106, A225107, A225553, A225554, A22555, A225972, A225973, A226214, A226215, A226216, A226217, A226218, A226910
RECALLING FIRM/MANUFACTURER Allen Medical Systems, Inc., Acton, MA, 
REASON C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity
VOLUME OF PRODUCT IN COMMERCE 83 units
DISTRIBUTION Nationwide and Internationally

 

PRODUCT Model 750 24' MRI Reusable/Disposable Circuit Accessory for use with Model 750 Portable Ventilator. 
CODE p/n 802-1750-05, no expiration; 802-17850-24
RECALLING FIRM/MANUFACTURER Impact Instrumentation, Inc., West Caldwell, NJ, 
REASON Product does not have a 510(k).
REASON Pishon Trading dba Eyezone have distributed soft color lens while on FDA hold and were later found to be misbranded.
VOLUME OF PRODUCT IN COMMERCE 564 units
DISTRIBUTION Nationwide

 

PRODUCT Dimension(R) Creatinine Flex(R) Reagent Cartridges. The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista System. Catalog number DF33A.
CODE Lot numbers: GA2196, GA2203, DC2221, DB2221, GA2229 and FA2237.
RECALLING FIRM/MANUFACTURER Siemens Healthcare Diagnostics, Inc., Newark, DE, 
REASON Siemens has confirmed the potential for falsely elevated creatinine results when processing tests from a well that has been punctured.
VOLUME OF PRODUCT IN COMMERCE 31,680 units
DISTRIBUTION Nationwide and Internationally

 

PRODUCT Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis. 
CODE Serial number: 1496-029792.
RECALLING FIRM/MANUFACTURER Spacelabs Healthcare, LLC, Issaquah, WA, 
REASON Due to software error.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MI

 

PRODUCT Computed Tomography X-Ray Systems (Brilliance 64, Model Number: 728231; Brilliance Big Bore, Model Number: 728243; Brilliance iCT, Model Number: 728306; Brilliance iCT SP, Model Number: 728311; and Ingenuity CT, Model Number: 728326). Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
CODE None
RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc., Cleveland, OH,
REASON The Common Image Reconstruction System (CIRS) on the affected Brilliance Systems encounters an error and requires reboot of the system. The unit failed to initialize axial scan due to timeout that occurred waiting for "READY" state
VOLUME OF PRODUCT IN COMMERCE 548 units
DISTRIBUTION Nationwide and Internationally

 

PRODUCT
1) Natural-Knee II Durasul All-Poly Patella, Size 0, 7mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. 
 
2) Natural-Knee II Durasul All-Poly Patella, Size 1, 7mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. 
 
3) Natural-Knee II Durasul All-Poly Patella, Size 2, 7mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. 
 
4) Natural-Knee II Durasul All-Poly Patella, Size 3, 7mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty.
 
5) Natural-Knee II Durasul All-Poly Patella, Size 0, 10mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. 
 
6) Natural-Knee II Durasul All-Poly Patella, Size 1, 10mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. 
 
7) Natural-Knee II Durasul All-Poly Patella, Size 2, 10mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. 
 
8) Natural-Knee II Durasul All-Poly Patella, Size 3, 10mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. 
CODE
1) 6301-07-100; all lots;
2) 6301-07-101; all lots;
3) 6301-07-102; all lots;
4) 6301-07-103; all lots;
5) 6301-10-104; all lots;
6) 6301-10-105; all lots;
7) 6301-10-106; all lots;
8) 6301-10-107; all lots
RECALLING FIRM/MANUFACTURER Zimmer Inc., Warsaw, IN,
REASON The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highly cross-linked polyethylene, Durasul, patella was shown to have a lower fracture fatigue strength than the Sulene counterpart and that the cement technique used by the surgeon can lead to insufficient fixation where it reduces the fatigue strength by 50-60%. Design differences as compared to other all-poly patella designs including a smaller cement groove contact area, the shape of the edge of the cement grooves, and smaller pegs affect the fracture fatigue strength. Also, it is hypothesized that a free-handed unlevel resection of the patella bone could result in residual stresses that reduce the fixation integrity of the patella implant.
VOLUME OF PRODUCT IN COMMERCE 111,454 units
DISTRIBUTION Nationwide and Internationally

 

PRODUCT Siemens AXIOM Aristos FX Plus solid state x-ray imager. Image-intensified fluoroscopic x-ray system. 
CODE Serial number 1273.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA,
Manufacturer: Siemens AG, Medical Solutions, Business Unit XP, Erlangen, Germany. .
REASON Fixation bolts for the mounting of the X-ray tube holder became mixed with an incorrect bolt type
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

 

PRODUCT Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , 4 units per box. units per box. Part Number: 0505-585-000 Match Ground Four facet Tip Introduction Needle - PIN 0306-130-011 13G Bevel Tip Stylet - PIN 0306-131-012 The intended use of the Stryker PCD System is for mixing bone cement and delivering it percutaneously. Bone cement is mixed in the chamber then transferred directly into an extension nozzle which has been attached to the introduction needle in the fracture site by a luer lock fitting. Cement is then dispensed directly into the fracture site under fluoroscopy. 
CODE Lot: 11223012 13G
RECALLING FIRM/MANUFACTURER Stryker Puerto Rico, Arroyo, PR, 
REASON Product was packaged with a four inch needle in stead of the correct five inch needle. There is a potential that the needle may not be able to reach the fracture site, which may require additional medical intervention. In addition, if the stylet needs to be changed and the additional stylet that comes in the package is used, this additional stylet is one inch longer than the needle. which could lead to a more serious injury and require additional medical intervention.
VOLUME OF PRODUCT IN COMMERCE 46 boxes (184units)
DISTRIBUTION Nationwide

 

PRODUCT
1) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4 mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12100805 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
2) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102604 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
3) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102605 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
4) AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102606 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
5) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102611 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
6) AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102613 --- Made in the USA--- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
7) AngioDynamics Morpheus Smart PICC CT 55cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 5mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102616 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
8) AngioDynamics Morpheus Smart PICC CT 55cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 5mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102617 --- Made in the USA ---  indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
9) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102805 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
10) AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102806 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
11) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102812 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
12) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102813 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
13) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102821 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
 
14) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102829 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
15) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104605 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
16) AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104606 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
17) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104612 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
18) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104805 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
19) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104813 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
20) AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104814 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
 
21) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104821 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
22) AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104830 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
23) AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/SEC --- Catalog No.: 12110904 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
24) AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110917 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
25) AngioDynamics Morpheus Smart PICC CT 6F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 6mL/sec --- Catalog No.: 12110918 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
26) AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110919 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. ;
 
27) AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110923 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
28) AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110929 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
29) AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110934 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. ;
 
30) AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110936 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
 
31) AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110937 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
32) AngioDynamics Morpheus Smart PICC CT 6F Triple Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110941 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
33) AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52100602 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
34) AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52102618 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
35) AngioDynamics Special Order Morpheus Smart PICC CT 65cm 6F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 6mL/sec --- Injector Pressure Limit --- Catalog No.: 52102624 --- Made in the USA--- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
 
36) AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52102638--- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. 
CODE
1) FG Lot Numbers: 553481, 554552;
2) FG Lot Number: 552392, 554557;
3) FG Lot Number: 551897, 552393, 552394, 553196, 553197, 554085, 554558, 554559;
4) FG Lot Number: 550962, 551912, 552395, 555170;
5) FG Lot Number: 551899, 553211, 553482, 55408;
6) FG Lot Number: 554561;
7) FG Lot Number: 553483;
8) FG Lot Number: 555930;
9) FG Lot Number: 551900, 552398, 552399, 553200, 554077, 554563;
10) FG Lot Number: 553486;
11) FG Lot Number: 553480, 554088;
12) FG Lot Number: 552440;
13) FG Lot Number: 553193;
14) FG Lot Number: 553487;
15) FG Lot Number: 552444, 553205, 553488, 554079;
16) FG Lot Number: 552445;
17) FG Lot Number: 553948, 554090;
18) FG Lot Number: 55244;
19) FG Lot Number: 553213;
20) FG Lot Number: 552450, 553208, 554091, 557219;
21) FG Lot Number: 553949;
22) FG Lot Number: 554081;
23) FG Lot Number: 551915, 553495;
24) FG Lot Number: 552452, 553216;
25) FG Lot Number: 552454, 554541, 554576;
26) FG Lot Number: 551529, 553405, 554573;
27) FG Lot Number: 552455, 553217;
28) FG Lot Number: 551762, 552457;
29) FG Lot Number: 552459, 551536, 553499;
30) FG Lot Number: 553333, 553760, 558278;
31) FG Lot Number: 553761;
32) FG Lot Number: 553218, 554092;
33) FG Lot Number: 553407, 554413;
34) FG Lot Number: 554082, 554554;
35) FG Lot Number: 552387, 553194;
36) FG Lot Number: 552388, 553291, 554555, 555166
RECALLING FIRM/MANUFACTURER
Recalling Firm: Angiodynamics Worldwide Headquarters, Latham, NY, .
Manufacturer: Angiodynamics, Inc., Queensbury, NY. 
REASON The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
VOLUME OF PRODUCT IN COMMERCE 10,392 units
DISTRIBUTION Nationwide

 

PRODUCT FloWire Doppler Guide wires. The Volcano FloWire Doppler guide wire is a single use guide wire intended for use in all blood vessels including both coronary and peripheral arteries to measure blood flow velocities during diagnostics angiography and/or interventional procedures. Part number 1400. 
CODE
Serial numbers 011-0318-002; 011-01323-012; 011-01319-001; 011-01319-002, 011-01319-005, 011-01319-006; 011-01319-007; 011-01318-001, 011-01321-003, 011-01321-006; 011-01321-008; 011-01321-009; 011-01322-001, 011-01323-010
RECALLING FIRM/MANUFACTURER Volcano Corp., Rancho Cordova, CA, 
REASON Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap.
VOLUME OF PRODUCT IN COMMERCE 14 units
DISTRIBUTION Nationwide, Japan and Europe

 

PRODUCT GEMINI TF 16 PET/CT System & GEMINI TF 64 PET/CT System. The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, head, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: -The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders. -The detection, localization, and staging of tumors and diagnosing cancer patients. -Treatment planning and interventional radiology procedures. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. 
CODE Serial Number 7224; Serial Number 7217
RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 
REASON Philips became aware of an issue relating to a UPS cabinet that contained a melted battery which caused damage to other batteries lower in the cabinet, leading to battery acid leaking on the floor.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION Nationwide

 

PRODUCT Broselow/Hinkle Pediatric Emergency System. The system supplies you with all the information and equipment needed for a young patients' emergency resuscitation requirements, all contained in a color coded, easy-to-use kit. Class 1 Exempt Device No Medical Device Listing Number exp date - 13 months from the date received by the distributor. Povidone Iodine Pads: The Povidone Iodine Pad is packaged in the Busse IV Start Kit that is included in the Intra Venous Module, which is contained in the Broselow products referenced below. Affected Armstrong product numbers: Kits: AE-4700, AE 4701, AE-4712, and PBL-PC-9A Modules: 7700RIV, 7700PIV, 7700YIV, 7700WIV, 7700BIV, 7700OIV, 7700GIV, 7730RED, 7730PUR, 7730YEL, 7730WHI, 7730BLU, 7730ORG, and 7730GRN Affected Vital Signs product numbers: Kits: 7730ALS, 7730IALS, 7730FLY, 7730MOD Modules: 7700RIV2, 7700PIV2, 7700YIV2, 7700WIV2, 7700BIV2, 7700OIV2, 7700GIV2, 7730RED5, 7730PUR5, 7730YEL5, 7730WHI5, 7730BLU5, 7730ORG5, and 7730GRN5 Sub-Assembly: 7700RIV, 7700PIV, 7700YIV, 7700WIV, 7700BIV, 7700OIV, and 7700GIV.
CODE Lot codes: 2008: 228F-366F 2009: 010K-258K and 010L-258L
RECALLING FIRM/MANUFACTURER Vital Signs Devices, a GE Healthcare Co., Totowa, NJ,
REASON Povidone Iodine Pads included in the Vital Signs Broselow Pediatric Emergency Kit may be contaminated with Elizabethkinga meningoseptica.
VOLUME OF PRODUCT IN COMMERCE 6675 units with 20166 pads in kits
DISTRIBUTION Nationwide

 

PRODUCT Foot Rest Kit (pN 6252700-003) for Models 6251 and 6252 Stryker (EMS Stair -PRO), OE 2065939, 1739631, 2066066, 6066803 and 20666941 with optional. Intended to provide the patient greater comfort and a sense of security. 
CODE None
RECALLING FIRM/MANUFACTURER Stryker Medical Division of Stryker Corp., Portage, MI, 
REASON The Foot Rest Kit may have the wrong pivot spacers making the joint more susceptible to relaxation and prone to fatigue. There is a moderate risk of injury to the patient should the handles become detached during use.
VOLUME OF PRODUCT IN COMMERCE 3 kits
DISTRIBUTION MI, MA

 

PRODUCT
1) Blanketrol II 48C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R. The Blanketrol II 48C System provides a flow of temperature-controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm/cool the fluid that enters and exits a heat exchanger. The conductive heat/cool transfer is accomplished through any type of blood oxygenator/heat exchanger unit. The operator of the unit regulates the desired fluid temperature. Frequent observation of the actual blood/fluid temperature and body temperature is required. The Blanketrol II 48 degree C does not contact the patient or the fluids; the water being circulated by the Hemotherm is separated from the fluid by the heat exchanger. To active temperatures above 42 Degrees C, the user must follow explicit instructions in to the owner's manual in order to activate the higher setting. Without following the explicit instructions, the device can only operate within the normal maximum temperature range of: 42 degrees C. The Blanketrol II 48 Degree C System can be used with adult and pediatric patients for extracorporeal circulation of the patient's limb, entire body, or a chemo medication lavage of the abdominal area. The 48C Blanketrol device is used to lower/raise the blood/fluid temperature and/or maintain blood/fluid temperature, as required, through conductive heat transfer. The conductive heat transfer is accomplished through any type of Blood Oxygenator/Heat Exchanger unit. This device is intended to hyperthermic treatment of AIDS and cancer patients and associated research. The device can be set to reach an upper temperature of: 48 degrees C.
 
2) Hemotherm 48C Dual Reservoir Heater/Cooler System, Model Number: 400 and Model Number: 400MR. The 48 o ( Degree) C Hemotherm Dual Reservoir Heater/Cooler I provides a flow of temperature-controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm/cool the fluid that enters and exits a heat exchanger. The conductive heat/cool transfer is accomplished through any type of blood oxygenator/heat exchanger unit. The operator of the unit regulates the desired fluid temperature. Frequent observation of the actual blood/fluid temperature and body temperature is required. The Hemotherm does not contact the patient of the fluids; the water being circulated by the Hemotherm is separated from the fluid by the heat exchanger. To active temperatures above 42 Degrees C, the user must follow explicit instructions in to the owner's manual in order to activate the higher setting. Without following the explicit instructions, the device can only operate within the normal maximum temperature range of: 42 degrees C. The Hemotherm can be used with adult and pediatric patients for extracorporeal circulation of the patient's limb, entire body, or a chemo medication lavage of the abdominal area. The Hemotherm 48C device system is used to lower/raise the blood/fluid temperature and/or maintain blood/fluid temperature, as required, through conductive heat transfer. The conductive heat transfer is accomplished through any type of Blood Oxygenator/Heat Exchanger unit. This device is intended to hyperthermic treatment of AIDS and cancer patients and associated research. The device can be set to reach an upper temperature of: 48C.
CODE
1) Serial Numbers: 902-8645, 902-8646, 911-9426, 914-10001, 914-10140, 914-10177, 943-12074, 992-14052, 994-14290, 994-14291, 002-14541, 002-14545, 012-15024, 014-15260, 022-15490, 074-18981, 962-12825, and 874-6277;
 
2) Serial Numbers: 862-8586M, 882-9143M, 882-9163M, 914-9837M, 952-10505M, 973-10918M, 992-11343M, 002-11540M, 003-11585M, 003-11586M, 003-11592M, 003-11600M, 004-11830M, 004-11631M, 014-11807M, 0311-12041M, 042-12250M, 071-12654M, 071-12655M, 073-12117M, 972-10872M, 062-12536M, and 963-10737M.
RECALLING FIRM/MANUFACTURER Cincinnati Sub-Zero Products Inc., Cincinnati, OH, 
REASON The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of AIDS and Cancer patients, were not appropriately cleared by the FDA prior to distribution.
VOLUME OF PRODUCT IN COMMERCE 20-Hemotherm 48C, 400M &400MR systems; and 16 Blanketrol II Model 222 & 222R 48C System units were distributed in U.S (rest shipped overseas).
DISTRIBUTION Nationwide

 

PRODUCT Siemens CLINITEST hCG -Pregnancy Test (qualitative), Radio immunoassay,Human Chorionic Gonadotropin (hCG) test system. Package of 25. Product Code 1760/ Catalog# 06484105). For in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens. 
CODE
Lot Expiration 028619, 6/8/2012; 028924, 7/5/2012; 029997, 10/7/2012; 030240, 11/6/2012; 030431, 11/24/2012; 030602, 12/8/2012; 030826, 12/24/2012; 030998, 1/11/2013; 031332, 2/4/2013; 031460, 2/19/2013; 031662, 3/6/2013; 031798, 3/20/2013; 031924, 3/30/2013; 032180, 4/28/2013; and 032106, 4/19/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Healthcare Diagnostics, Tarrytown, NY,    
Manufacturer: Alfa Scientific Designs Inc., Poway, CA. .
REASON A potential for false positive or increase in borderline results with patients and commercially available negative control material.
VOLUME OF PRODUCT IN COMMERCE 48,578 Kits (25 tests / kit)
DISTRIBUTION Nationwide and Internationally

 

PRODUCT
1) AU Clinical Chemistry Analyzers: Model Number: AU400 Clinical Chemistry Analyzer, AU400(e) Clinical Chemistry Analyzer, AU480 Clinical Chemistry Analyzer. The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay. Recall # Z-0974-2012;
 
2) AU Clinical Chemistry Analyzers: Model Number: AU600 Clinical Chemistry Analyzer, AU640 Clinical Chemistry Analyzer, AU640(e) Clinical Chemistry Analyzer, AU680 Clinical Chemistry Analyzer. The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay. 
 
3) AU Clinical Chemistry Analyzers: Model Number: AU2700 Clinical Chemistry Analyzer . The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay. ;
 
4) AU Clinical Chemistry Analyzers: Model Number: AU5400 Clinical Chemistry Analyzer. The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay.
CODE All analyzer serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, 
Manufacturer: Beckman Coulter Kk, Sunto-gun, Japan. 
REASON The AU Clinical Chemistry Analyzers may experience cuvette overflow.
VOLUME OF PRODUCT IN COMMERCE 8,225 units
DISTRIBUTION Nationwide and Internationally

 

PRODUCT Terumo, Sarns Sternal Saw I System, Catalog 6090. The Sarns Sternal Saw I is indicated for use in splitting the sternum during thoracic surgery. 
CODE Serial Numbers 0 - 10186
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems Corp, Ann Arbor, MI, 
REASON Terumo Cardiovascular Systems has received one report of minute metal shavings leaking from the Sarns Sternal Saw I System at the point where the saw blade is inserted into the saw handpiece.
VOLUME OF PRODUCT IN COMMERCE 10187
DISTRIBUTION Nationwide and Internationally

 

PRODUCT
1) EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems. 
 
2) EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems.
 
3) EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems. 
 
4) EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems. 
 
5) EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems. 
CODE
1) Lot Numbers: 14050236, 14069164, 14085850, 14085852, 14089636, 14098511, 14102112, 14138785, 14142301, and 15091243;
 
2) Lot Numbers: 15214996M, 14070102A, 15177599, 15156690, 15156649, 15123384, 15111287, 15079216, 15076033, 15070702, 14138791, 14117351, 14117345, 14117339, 14113236, 14109201, 14102119, 14102116 14093807, 14091431, 14087720, 14081176, 14077787, 14076743, 14075452, 14071539, 14071538, 14068519, 14066570, 14064255, 14060307, 14058853, 14058117, 14056270, 14056269, 14053165, 14052248, 14052247, 14049472, 14043262, 14040370, 14039651, and 14036714
 
3) Lot Numbers: 15076036, 15076035, 15059708, 14113238, 14105865, and 13439370;
 
4) Lot Numbers: 15221536M, 15215004M, 15215001M, 15215000M, 15208579M, 15208577M, 15208574M, 14069262A, 14069168A, 14069084A, 15164269, 15164264, 15159917, 15159912, 15156608, 15148849, 15144223, 15128115, 15128113, 15119884, 15119883, 15116509, 15116506, 15103250, 15098193, 15098191, 15098190, 15095199, 15083389, 15083386, 15080818, 15080815, 15070703, 15067809, 15064960, 15032155, 15014525, 15014522, 15014521, 15010028, 15010027, 15007251, 15007250, 14152525, 14149131, 14149130, 14149129, 14146082, 14142307, 14138855, 14138853, 14138846, 14138795, 14120030, 14117394, 14117388, 14117385, 14117376, 14117371, 14117370, 14117356, 14113251, 14113249, 14109218, 14109216, 14102071, 14102068, 14097083, 14095220, 14093166, 14092574, 14091435, 14089642, 14089641, 14088995, 14087721, 14080304, 14080303, 14080302, 14079405, 14078387, 14078385, 14077789, 14075460, 14075459, 14071639, 14071638, 14071542, 14070108, 14068526, 14067399, 14065778, 14065064, 14065059, 14064262, 14064259, 14064258, 14063230, 14062655, 14062654, 14062652, 14062651, 14062042, 14062040, 14062039, 14062038, 14061249, 14060315, 14060311, 14058856, 14058855, 14057214, 14056275, 14056273, 14056272, 14053738, 14053167, 14052547, 14052249, 14051584, 14043263, 14042518, 14042517, 14038851, 14036716, 14036583, and 14036582;
 
5) Lot Numbers: 15219359M, 15219356M, 15214930M, 15214908M, 15214902M, 15208638M, 15208634M, 15208631M, 15208628M, 15208626M, 15208619M, 15208612M, 15208607M, 15208593M, 15205050M, 15205047M, 15205031M, 15205018M, 15204883M, 15199820M, 15199819M, 15199811M, 15199801M, 15199794M, 15199792M, 14069263A, 15171668, 15171665, 15171663, 15171652, 15169965, 15169957, 15169946, 15164293, 15164271, 15159938, 15159935, 15159922, 15156563, 15151976, 15148785, 15148772, 15144234, 15144151, 15144134, 15144119, 15136209, 15132418, 15128133, 15128123, 15124171, 15124167, 15123408, 15120034, 15120022, 15116441, 15103256, 15103255, 15098206, 15098200, 15098198, 15098195, 15095224, 15095223, 15095220, 15091259, 15091254, 15083409, 15081335, 15081333, 15076058, 15076049, 15076046, 15071044, 15070717, 15070708, 15067823, 15067817, 15057475, 15040868, 15035767, 15035766, 15032160, 15028721, 15028712, 15028708, 15028701, 15025094, 15021180, 15021179, 15021175, 15021168, 15021164, 15021163, 15021148, 15017983, 15010043, 15010040, 15010033, 15010006, 15009982, 15009980, 15009978, 15009975, 15007267, 15007261, 15007255, 15007254, 14152530, 14149138, 14149136, 14146104, 14146099, 14146095, 14146090, 14146086, 14146084, 14142340, 14142339, 14142335, 14142333, 14142326, 14142325, 14142324, 14142323, 14142322, 14142317, 14142316, 14142314, 14142312, 14142311, 14138878, 14138878, 14138871, 14138866, 14138865, 14138864, 14138860, 14138859, 14120108, 14120105, 14120100, 14120092, 14120078, 14120076, 14120075, 14120067, 14120062, 14120055, 14120015, 14120014, 14120010, 14120006, 14120002, 14120000, 14119986, 14119985, 14119977, 14117438, 14117431, 14117430, 14117429, 14117409, 14117406, 14117404, 14117400, 14117398, 14113274, 14113268, 14113262, 14113257, 14109239, 14109234, 14109231, 14109230, 14109229, 14109228, 14102076, 14099138, 14099135, 14098716, 14098709, 14098706, 14098530, 14098525, 14097835, 14095223, 14090358, 14089643, 14088997, 14088996, 14087736, 14087731, 14085863, 14085143, 14085142, 14085141, 14081912, 14081911, 14081907, 14081809, 14081808, 14081805, 14081804, 14081185, 14080312, 14080310, 14079411, 14078390, 14076755, 14076256, 14076254, 14076253, 14075465, 14075464, 14071644, 14071547, 14068530, 14066590, 14066582, 14065792, 14065065, 14064778, 14064271, 14064266, 14064265, 14063238, 14063236, 14063234, 14062663, 14062660, 14062044, 14061259, 14061256, 14060323, 14060321, 14060320, 14058864, 14058857, 14058125, 14058124, 14058122, 14057221, 14057220, 14053745, 14053740, 14053739, 14053728, 14053724, 14053709, 14053168, 14052551, 14050933, 14049476, 14043896, 14042520, 14039654, 14038050, 14029870, 14029043, 14028071, 14027237, 14025878, 14025127, 14019684, 14016117, and 13435854
RECALLING FIRM/MANUFACTURER Biosense Webster, Inc., Irwindale, CA,
REASON Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers. 2. To minimize risk of atrio-esophageal fistula, precautionary measures should be taken when ablating on posterior wall of the left atrium in proximity to the esophagus. This issue affects only the IFU for the EZ Steer ThermoCool NAV Diagnostic/Ablation Catheter, not the catheter itself. Please note that these warnings and precautions are already included in the NaviStar ThermoCool Catheter IFU. Both of these potential complications, and procedural mitigations for avoiding them, are well documented in clinical and scientific literature.
VOLUME OF PRODUCT IN COMMERCE 24,713 units
DISTRIBUTION Nationwide

 

PRODUCT VITROS Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710. An in vitro diagnostic. For in vitro diagnostic use only. Used to quantitatively measure valproic acid (VALP) concentration in human serum and plasma. 
CODE
Reagent Lots from Generation (GEN) 14: 1511-14-9637 (exp. 6/30/11), 1511-14-9776 (exp. 9/30/11), 1511-14-9894 (exp. 11/30/11), 1511-14-1094 (exp. 1/31/12), and 1511-14-1230 (exp. 4/30/12)
RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Rochester, NY,
REASON Results using VITROS Chemistry Products VALP Reagent were negatively biased compared to other manufacturers. OCD confirmed that patient results were also affected by this issue.
VOLUME OF PRODUCT IN COMMERCE Approximately 5836 units
DISTRIBUTION Nationwide and Internationally

 

PRODUCT Integra OS Osteoconductive Scaffold Putty (a 2.5 cc Part numbers - IOS10125; b) 5 cc Part numbers - lOS10155). Integra OS Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system. Following placement in the bony void or gap (defect), Integra OS Putty is resorbed and replaced with bone during the healing process.
CODE a) Lot numbers - N199416 and 215944; b) Lot numbers - 208500, 206504 and N216026
RECALLING FIRM/MANUFACTURER Integra LifeSciences Corp, Plainsboro, NJ,
REASON Integra OS Osteoconductive Putty is labeled with incorrect storage conditions.
VOLUME OF PRODUCT IN COMMERCE 45 units
DISTRIBUTION Nationwide

 

PRODUCT Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX- 882140. Philips Healthcare. Used to do nuclear medicine diagnostic imaging of various body organs. 
CODE
System Code # 882130, Serial # 10, 97, 101, 103, 104, 107-112, 116, 117, 119-121, 123, 125, 127, 130, 132, 133, 135, 138, 142-144, 149-151, 153-158, 162-164, 166, 169-173, 180, 181, 185, 186, 189, 193-204, 214, 215, 218, 219, 221-223, 227, 229-231, 233-237, 240, 242, 244-246, 249-251, 260-262, 264, 267, 272, 273, 275, 277, 280, 281, 283, 285, 291-293, 295, 297-300, 305, 308-310, 312, 316, 319-322, 326-332, 334-336, 338-340, 346, 347, 349, 351, 352, 354, 355, 358-363, 368-370, 374, 377-379, 385, 387, 388, 390-396, 401-407, 411, 412, 416-419, 426-432, 434, 437, 438, 442, 443, 445-447, 449, 452, 457-462, 464, 465, 468, 471, 474, 480-485, 487, 490-493, 495, 496, 499, 502, 503, 505, 508, 509, 511, 513-518, 520, 521, 523, 529, 530, 534, 543-546, 548-560, 562, 563, 569-572, 574-576, 580, 582, 583, 585, 586, 590, 594, 595, 597, 602-607, 611, 612, 618-621, 624-628, 630, 635, 636, 640, 641, 647-650, 654, 656-658, 660-665, 668-673, 675, 679, 681-684, 686, 687, 690-695, 697-699, 701-708, 711-719, 723-729, 733-736, 738, 739, 743-746, 749-753, 755, 756, 759, 760, 762, 764-767, 771-773, 776-778, 780, 781, 786, 789, 790-795, 797, 799, 801, 803-806, 808, 809, 811-814, 818, 820-822, 825-827, 831-834, 836, 837, 839, 840, 841, 843-845, 848, 849, 851-855, 857, 858, 860-862, 865-869, 872-874, 876-881, 884-886, 889, 893, 894, 900-903, 907-922, 924, 927-930, 932, 934, 938-941, 943, 944, 946-948, 951, 953, 954, 958-963, 965-967, 970, 972-980, 982, 983, 985, 986, 991-994, 996-1000, 1003-1008, 1010-1013, 1016, 1017, 1019, 1022, 1023, 2007, 2008, 211037, 2008-0068, 555A, & 778A. System Code #882140, Serial # 102, 134, 141, 146, 147, 159, 160, 161, 167, 175, 176, 190, 209, 210, 216, 225, 226, 257, 259, 268-270, 274, 289, 290, 302, 304, 314, 315, 318, 323, 333, 341, 343, 344, 348, 350, 364, 366, 381, 386, 409, 414, 420, 421, 423, 436, 441, 455, 463, 469, 472, 473, 488, 489, 497, 498, 501, 531, 532, 536-539, 565, 566, 578, 588, 589, 591, 596, 598-600, 608, 610, 613, 615, 616, 622, 631, 632, 634, 637, 653, 666, 674, 676-678, 685, 689, 700, 709, 710, 731, 732, 741, 742, 748, 757, 763, 768, 774, 785, 802, 810, 816, 819, 824, 828, 829, 830, 838, 846, 856, 863, 864, 870, 871, 875, 884, 891, 892, 898, 904, 905, 931, 933, 936, 942, 945, 949, 950, 952, 955-957, 964, 968, 981, 989, 990, 995, 1001, 1002, 1009, 1015, 1018, & 1021. System Code #882130/40, Serial #184, 730, 122, 136, 254, 255, 284, 614, 696, 874, 906, & 984. System Code #882140/882130, Serial #113, 148, 152, 178, 179, 187, 188, 217, 238, 243, 247, 248, 278, 288, 345, 367, 371, 373, 380, 384, 389, 397, 397, 399, 408, 413, 415, 435, 439, 439, 440, 453, 477-479, 486, 504, 512, 525, 526, 528, 533, 535, 540, 547, 564, 567, 568, 577, 579, 581, 638, 639, 644, 645, 651, 652, 659, 667, 680, 747, 758, 815, 850, 859, 882, 883, 890, 896, 897, 899, 925, & 969.
RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 
REASON Philips was informed that the detector buckets may experience weakness over time. As a result, this could cause the detector bucket to separate from the mounting plate of the gantry and eventually result in the detector falling.
VOLUME OF PRODUCT IN COMMERCE 795 units
DISTRIBUTION Nationwide and Internationally

 

PRODUCT Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) Part number: 8900-0401 Used in connection with Zoll M Series and E series Defibrillators specifically for pediatric patients. 
CODE Lot Numbers 0510 thru 4511
RECALLING FIRM/MANUFACTURER Bio-Detek, Inc., Pawtucket, RI,
REASON Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter.
VOLUME OF PRODUCT IN COMMERCE 3,080 units
DISTRIBUTION Nationwide and Canada

 

PRODUCT
1. Model #03001-02: Periophil Biphasic, Synthetic Biphasic Dental Bone Graft Granules, 1.0 cc. Model # 03003-01 Periobase Biphasic: Periobase, Synthetic Biphasic Dental Bone Biphasic Granules, 0.5 cc. Model #03002-01: Periobone Biphasic, Synthetic HA/TCP Dental Bone Graft Biphasic Granules, 0.5 cc. Periophil Biphasic (synthetic grafting material) is intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects.
CODE
1. Lot # Z13-927A, expiration date 2/1/2014; 2. 03001-02 Periophil Biphasic, Lot # Z13-927B, expiration date 2/1/2014. 3. 03001-01 Periophil Biphasic, Lot # Z13-926A, expiration date 2/1/2014. 4. 03001-01 Periophil Biphasic, Lot # N13-925C, expiration date 1/31/2014. 5. 03003-01 Periobase Biphasic, Lot # N13-925B, expiration date 1/31/2014. 6. 03002-01 Periobone Biphasic, Lot # N13-925A, expiration date 1/31/2012.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cytophil, Inc., East Troy, WI,
Manufacturers: Cytophil, Inc., East Troy, WI;
Steris Isomedix Services, Libertyville, IL. 
REASON Devices were inadvertently shipped after receiving an inadequate dose of radiation and this product may not be sterile.
VOLUME OF PRODUCT IN COMMERCE 547
DISTRIBUTION Nationwide

 

PRODUCT Temporary Pacing Wire, BIPOLAR, Models a) BM, b) V, c) VE and d) VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Shipping or Unit Package: 20 individual units packaged per box with 6 boxes per case. --- Device Classification Name: Electrode, pacemaker, temporary. The device is supplied sterile and intended for single use. Used to pace the heart during or after open heart surgery. The electrodes are placed on the heart; the other end of the pacing wire is inserted through the skin of the patient with a thoracic needle. The thoracic needle can snap-off at the end where the pacing wire is attached, after snap-off the remaining pins are connected to an external pacemaker. For temporary atrial and ventrical pacing and sensing for contemplated implant duration of 7 days or less. 
CODE
a) Lot numbers 1101044-10, 1012035-10, 1012036-10, 1011128-10, 1101023-10, 1101134-10, 1102035-10, 1102061-10, 1009089-10; b) Lot number: 1103066-10; c) Lot numbers: 1101055-10, 1101008-10; d) Lot numbers: 1011092-10, 1011148-20, 1012038-10, 1101021-10, 1101136-10
RECALLING FIRM/MANUFACTURER European Custom Manufacturing B.V, Gemert, Netherlands
REASON The crimping operation during product production was not performed properly. As such, the pacing wire may separate from the connection pin, which causes non-functionality.
VOLUME OF PRODUCT IN COMMERCE 2,120 individual units (106 boxes)
DISTRIBUTION Nationwide

 

PRODUCT Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination with a Leica M822 Optics Carrier-XY-Focus-Tilt-Unit, article #10448587; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201. The intended use of the microscope is for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment. The corrected units will have controller software version MDC V3.6 pack G. 
CODE
Serial numbers: 181011001, 181011009, 181011005, 181011003, 250811007, 28101108, 151111011, 211111007, 251111006 and 251111004
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leica Microsystems, Inc., Buffalo Grove, IL, .   
Manufacturer: Leica Microsystems (Schweiz) Ag, Heerbrugg, Switzerland.
REASON Leica Microsystems received complaints stating that the zoom function of the Leica M822 surgical microscope locked up during use.
VOLUME OF PRODUCT IN COMMERCE 29 units
DISTRIBUTION Nationwide, Austraila, Japan, Korea, Pakistan, Romania, South Africa, Switzerland and Turkey

 

PRODUCT SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for the identification of Staphylococcus aureus strains from culture media. Catalog #73113. 
CODE Lot number: 1105104545
RECALLING FIRM/MANUFACTURER
Recalling Firm: bioMerieux, Inc., Durham, NC, 
Manufacturer: Biomerieux Brasil, Rio De Janeiro, Brazil.
REASON Reports of false negative results in organism identification.
VOLUME OF PRODUCT IN COMMERCE100 kits
DISTRIBUTION CA

 

PRODUCT Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326. Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-asectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. 
CODE Serial Numbers: 300003, 300004, 300005, and 300010
RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 
REASON A 'gap' is created in the side covers when the gantry of the device is tilted to +30 degrees (forward tilt). A hazard to the operator/user presents itself if the operator puts his or her fingers or hand inside the gap and the gantry tilt is returned in position while the fingers or hand of the user are still in the gap.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION Nationwide, Australia and Germany
 
PRODUCT VARIANT II Link Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, For the determination of Hemoglobin A1c in human whole blood. Contents: Elution Buffer A , 1 x 2500 mL Elution Buffer B, 1 x 2100 mL Wash/Diluent Solution, 1 x 2500 mL Cartridge Set CD ROM - 1 Calibrator/Diluent Set Whole Blood Primer, 6 x 1 mL Sample vials, 2 x 100 Instruction Manual. Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HLCP). Catalog number: 270-2716. 
CODE Lot 70211322; 70211432, 70211440; exp 3/31/2012
RECALLING FIRM/MANUFACTURER Bio-Rad Laboratories, Inc., Hercules, CA
REASON It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units. The numbers are missing a decimal point.
VOLUME OF PRODUCT IN COMMERCE 63 units
DISTRIBUTION Nationwide

 

PRODUCT MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20. The intended use of the Cannula is the injection of fluids into, or withdrawal of fluids from, parts of the body below the surface of the skin. 
CODE Lot #1029402
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merz Aesthetics, Inc., Franksville, WI, 
Manufacturer: Tsk Laboratory, Tochigi City, Japan. .
REASON Recall due to a labeling error on the secondary (outer) packaging. The outer package label states that the carton contains Cannulas that are 27GA x 25 mm in size instead of 27G x 38 mm. Length of the cannula is a matter of user preference and is unlikely to impact patient safety.
VOLUME OF PRODUCT IN COMMERCE 5 boxes (20 units per box)
DISTRIBUTION Nationwide

 

PRODUCT
1) Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. 
 
2) Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae.
CODE
1) Lot # 7964576;
2) Lot # 7964590
RECALLING FIR/MANUFACTURER Micro Therapeutics Inc, dba ev3 Neurovascular, Irvine, CA,
REASON ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production.
VOLUME OF PRODUCT IN COMMERCE 27 units
DISTRIBUTION Nationwide, the UK and France

WEEK ENDING FEBRUARY 18

PRODUCT Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04 The Nemschoff Perinatal Bassinet products are wheeled carts with a top tray intended for an infant tray with mattress. The bassinets are intended for medical purposes that consist of a bed designated for the use of a pediatric patient. 
CODE Manufactured between 11/21/2003 and 04/04/2008. Bassinet tubs manufactured between 11/21/2003 to present
RECALLING FIRM/MANUFACTURER NEMSCHOFF, Sheboygan, WI, 
REASON To correct issues with casters, door hinges, drawer slides, and the bassinet surround. Also, to add labeling to the product regarding specific instructions for cleaning the bassinet tub and drawer weight limits.
VOLUME OF PRODUCT IN COMMERCE 1214 units
DISTRIBUTION Nationwide, and Canada
 
PRODUCT Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962. 
CODE Lot Numbers: 830567, 830568, 830569, 863004, 868509, 868519, 875226, 875227, and 897191
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc. Endoscopy Division, Andover, MA, .
Manufacturer: Smith & Nephew, Inc., Endoscopy Div., Mansfield, MA. 
REASON Manufacturing issue: The distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use.
VOLUME OF PRODUCT IN COMMERCE 1743 units
DISTRIBUTION Nationwide and Internationally

 

PRODUCT Pinnacle3 Radiation Therapy Planning System, software version 9.0. Model # Description 453560446041 Pinnacle3 version 9.0 English 453560446051 Pinnacle3 version 9.0 Simplified Chinese 453560446061 Pinnacle3 version 9.0 Traditional Chinese 453560446091 Pinnacle3 version 9.0 Dutch 453560446101 Pinnacle3 version 9.0 French 453560446111 Pinnacle3 version 9.0 German 453560446141 Pinnacle3 version 9.0 Italian 453560446161 Pinnacle3 version 9.0 Japanese 453560446181 Pinnacle3 version 9.0 Spanish 453560446201 Pinnacle3 version 9.0 Turkish Intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. 
CODE
System Code # 453560446041 453560446111 453560446041 453560446101 453560446041 453560446101 453560446041 453560446051 453560446041 453560446101 453560446041 453560446101 453560446041 453560446111 453560446041 453560446111 453560446051 453560446041 453560446141 453560446041 453560446161 453560446041 453560446161 453560446041 453560446181 453560446101 453560446041 453560446061 453560446041 453560446061 453560446041 453560446201 453560446041
RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland), Inc., Fitchburg, WI, 
REASON Phillips Medical Systems have recently determined that a software (Pinnacle3 Software version 9.0) nonconformance can cause incorrect beam geometry.
VOLUME OF PRODUCT IN COMMERCE 715 devices
DISTRIBUTION Nationwide and Internationally

 

PRODUCT GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1), a) Model # 882470 & GEMINI TF 64 PET/CT System (with software version 3.5.1 and 3.5.1.1), b) Model #882471. The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. 
CODE
a) Serial #'s: 7003-7006, 7008-7011, 7014, 7015, 7017-7026, 7031, 7034-7036, 7039, 7041, 7043, 7045, 7047, 7049, 7050-7054, 7058, 7060, 7062, 7064, 7066, 7068, 7069, 7073-7075, 7077, 7080, 7081, 7084-7087, 7089, 7093-7099, 7104, 7106-7108, 7112, 7114, 7115, 7118, 7120-7123, 7125, 7128, 7129, 7131, 7133, 7135, 7137-7140, 7142, 7143, 7145, 7147, 7148, 7156, 7159, 7161, 7163, 7165, 7166, 7168, 7170, 7173, 7174, 7176, 7177, 7181, 7183-187, 7193-7200, 7205, 7208, 7210, 7211, 7215, 7216, 7220, 7223 & 7224;  b) Serial #'s: 7007, 7012, 7013, 7016, 7027-7030, 7032, 7042, 7044, 7055, 7057, 7059, 7061, 7063, 7065, 7067, 7071, 7072, 7076, 7078, 7079, 7082, 7083, 7088, 7091, 7092, 7102, 7103, 7105, 7109, 7110, 7116, 7117, 7119, 7126, 7132, 7136, 7141, 7144, 7146, 7149, 7152-7154, 7158, 7160, 7164, 7167, 7169, 7171, 7172, 7175, 7178-7180, 7182, 7188-7190, 7192, 7201-7204, 7206, 7209, 7212-7214, 7217-7219 & 7221.
RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 
REASON Philips received notification by a customer of an issue relating to unwanted auto delete occurrences resulting in raw data being deleted and, in some cases, raw data being deleted immediately after scan acquisition but before images are reconstructed.
VOLUME OF PRODUCT IN COMMERCE 197 units
DISTRIBUTION Nationwide and Internationally

 

PRODUCT Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for in-vitro diagnostic use only. Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphine, 50 phencyclidine, 500 ng/m: oxazepam, 500 ng/mL secobarbital, 700ng/mL propoxyphene and 600 ng.mL methadone in urine buffer with dosium azide as preservitive. Drug abuse testing. Catalog 0804. 
CODE Lot number: 1101138K2, exp 1/28/2013
RECALLING FIRM/MANUFACTURER Lin-Zhi International Inc., Sunnyvale, CA, 
REASON Catalog # 0804 Multi-Analyte Urine DAU Intermediate Calibrators were incorrectly labeled and mistakenly filled with Catalog # 0805 DAU High Calibrators.
VOLUME OF PRODUCT IN COMMERCE 49 items
DISTRIBUTION Nationwide and Germany

 

PRODUCT R2 Adult R2 Non-Radiolucent Multifunction Electrodes, Catalog/REF No. 3200-1715, NON-STERILE, MADE IN USA. This device, when connected to a monitor/defibrillator has the ability to monitor the electro-cardio function (ECG) of the patient. The device, when electrically activated by the monitor/defibrillator can pace the heart rate of the patient and may also transmit the electrical current to the patient for cardio-conversion. This is a non-sterile, disposable device. 
CODE Lot 1010194
RECALLING FIRM/MANUFACTURER
Recalling Firm: ConMed Corp., Utica, NY, 
Manufacturers: ConMed Corp., Utica, NY;
Consolidated Medical Equipment Co, Chihuahua, Mexico.
REASON The specific lot was assembled without the rivet cover.
VOLUME OF PRODUCT IN COMMERCE 850 sets (2 pads per set in individual pouch)
DISTRIBUTION Nationwide, Canada, Belgium, Germany and Hong Kong

 

PRODUCT 5100-03-707 -- MOST Option STEM DISTRACTOR MATL: SS NONSTERILE QTY-1 Designed to facilitate intraoperative decisions with a variety of options for femoral and tibial components, implant connections and fixation of the implants. 
CODE Lots 1519123, 1616672, 1627174, 60281712, 60773654, 60795066, 60841064, 61061148, 61348637, and 61770544
RECALLING FIRM/MANUFACTURER Zimmer Inc., Warsaw, IN,
REASON Fractured tips: Any use of force in a certain direction to the flat side of the instrument may result in fracturing of the mating geometry, creating the potential for metal debris at the surgical site.
VOLUME OF PRODUCT IN COMMERCE 109 total
DISTRIBUTION Nationwide and Switzerland

 

PRODUCT Alaris PC unit model 8015. The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. 
CODE The affected units have unique serial numbers for traceability.
RECALLING FIRM/MANUFACTURER CareFusion 303, Inc., San Diego , CA,
REASON The recall was initiated because Carefusion has identified a potential risk with a PLD component on the Alaris PC unit model 8015 power supply board. The PLD component used in production between June 21, 2011 and August 15, 2011 has a higher standby current resulting in the battery depleting prematurely.
VOLUME OF PRODUCT IN COMMERCE 1,039 units
DISTRIBUTION Nationwide and Australia

 

PRODUCT enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges, Catalog # enGen -- Common/Usual Name: enGen(TM) Track System, Hettich Centrifuge -- For in vitro diagnostic use only. The VITROS 5,1 FS Chemistry System with enGen(TM) Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods). 
CODE All enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-Clinical Diagnostics, Rochester, NY, 
Manufacturers: Ortho-Clinical Diagnostics, Rochester, NY;
Thermo Fisher Scientific OY, Vantaa, Finland;
Andreas Hettich Gmbh & Co. Kg, Tuttlingen, Germany.
REASON Complaints of centrifuge buckets disconnecting from their supports during centrifugation when using the Hettich Rotanta 46 RSC Robotic Centrifuges, Models 4815, 4816 and 4817, that may be configured with enGen(TM) Laboratory Automation Systems.
VOLUME OF PRODUCT IN COMMERCE 78 units worldwide (18 Domestic and 68 Foreign)
DISTRIBUTION Nationwide and Internationally

 

PRODUCT The SIGMA HP Fixed Bearing Tibial Tray Impactor is part of a set of tools designed specifically for the installation of the PFC SIGMA Knee. SIGMA HP Fixed Bearing Tibial Tray Impactors Packaged in poly bag with optional protection from sharp or fragile points. Instruments are supplied non-sterile and do not have specified expiration date or shelf life. Usage: The Tibial Tray (with protective cover) and instrument are assembled outside of the patient in theatre; the tray is introduced and impacted into the cement containing tibia using the impactor. Once the tray is fully seated in the cement containing tibia, the instrument is intended to be removed. Catalog number 9505-01-306. 
CODE
All lots: 071089, 071812, 071989, 072017, 072219, 072220, 072221, 072222, 080026, 080027, 080028, 080029, 080319, 080336, 080337, 080338, 080403, 080404, 080405, 080406, 080407, 080632, 080633, 080634, 080635, 080841, 080842, 080843, 080844, 080845, 080846, 080847, 080848, 080849, 081138, 082151, 082152, 082153, 082175, 082176, 082177, 082178, 082260, 082261, 082262, 082263, 082264, 082265, 082266, 082267, 082268, 082269, 083106, 083107, 083108, 083109, 083110, 083111, 083400, 083401, 083402, 083403, 083404, 083405, 083406, 083407, 083408, 083409, 083495, 090237, 090238, 090239, 090240, 090241, 090242, 090933, 090934, 090935, 090936, 090937, 090938, 090939, 090940, 090941, 090942, 094951, 094952, 100059, 100060, 100172, 100173, 100174, 100455, 100456, 100457, 100458, 100459, 100460, 100469, 100470, 100787, 102110, 102111, 102616, 102617, 102618, 102619, 102620, 102621, 102622, 102623, 102624, 104779, 104780, 105278, 105279, 110046, 110047, 110343, 110344, 110345, 110725, 110726, 110727, 110728, 110729, 111011, 111012, 111013, 112537, 112538, and 112539
RECALLING FIRM/MANUFACTURER
Recalling Firm: DePuy Orthopaedics, Inc., Warsaw, IN,
Manufacturer: Enztec Ltd, Christchurch, New Zealand. 
REASON The impactor can become intentionally locked on the Tibial Tray implant during surgery.
VOLUME OF PRODUCT IN COMMERCE 1794 (398 in USA)
DISTRIBUTION Nationwide, Canada, Ireland and South Africa

 

PRODUCT Product is a 15x16x27" (WxDxH) air purifier device with one of two different brands next to the control panel: HealthWay or CleanStation. HealthWay brand is sold under model number Deluxe 20600-3 Air Purification System. The CleanStation brand is sold under model number CS20000. The devices are intended to remove particles from the air for medical purposes. 
CODE
Serial #’s: 08070001-08070425, 01080001-01080420, 13070001-13070415, 10080001-10080455, 33070001-33070458, 21080001-21080355, 34070001-34070455, 22080001-22080420, 35070001-35070455, 28080001-28080455, 36070001-36070455, 21080001-21080190, 38070001-38070395, 47080001-47080410, 39070001-39070455, 49080001-49080423, 45070001-45070195, 50080001-50080420, 42070001-42070455, 35090001-35090447, 43070001-43070455
RECALLING FIRM/MANUFACTURER
Recalling Firm: Healthway Home Products, Inc., Pulaski, NY,
Manufacturer: Shenzhen Healthway Elec Co. Ltd, Shenzhenshenzhen, China. 
REASON A potential risk of electrical arcing that could cause overheating or fire within the units.
VOLUME OF PRODUCT IN COMMERCE 9,107 units
DISTRIBUTION Nationwide and Canada

 

PRODUCT Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915. Nuclear magnetic resonance imaging system. 
CODE Serial numbers 45115, 41187, 41157, 41116, 45072, 45081, 41089, 41215, 41144, 41201, 45148, 41164, 41088, 41245, 41168, 41152, 45140, 45152, 45143, 45195, 41222, 41150, 45129, 45118, 45119, 41134, 41138, 45182, 45213, 41167, 41100, 52024, 45196, 45197, 41180, 41130, 45088, 41189, 41104, 41246, 41176, 45138, 15084, 41071, 45120, 45107, 41271, 45135, 45141, 41264, 45110, 41279, 41231, 41284, 41235, 45221, 45223, 41276, 41278, 41137, 41225, 41131, 41141, 41233, 45185, 41236, 41238, 45149, 41191, 45074, 45106, 45006, 45201, 41133, 41265, 41188, 45220, 41140, 41079, 45160, 45167, 41194, 45155, 45130, 41241, 41170, 45147, 41006, 45219, 45085, 45150, 45031, 41162, 45121, 45134, 45099, 45038, 45079, 41109, 41156, 45116, 41249, 45128, 45078, 45214, 41103, 45229, 41234, 45181, 52025, 52021, 45105, 45132, 41149, 45228, 45060, 45080, 45208, 41083, 45230, 45205, 41097, 41181, 45093, 45199, 45184, 45071, and 45111
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, 
Manufacturer: Siemens AG, Medical Solutions, Business Unit XP. Erlangen, Germany. 
REASON During product monitoring firm has discovered that on a few systems the gradient cable connections did not meet their specifications after installation. Locally, the cable connections overheated, making servicing necessary. The potential existed for a cable connection to become overheated, leading to the emission of smoke and possible material damage.
VOLUME OF PRODUCT IN COMMERCE 128 units
DISTRIBUTION Nationwide

 

PRODUCT Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MLC, Reference/FSCA CP-05591, Model Number: H53. Intended use: The Varian Millennium 120 Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac radiation therapy linear accelerator and is intended to shape the x-ray field perimeter. Field shape can either be static (fixed) or dynamic. Dynamic field shapes are controlled as a function of either Clinac dose fraction or gantry angle. The intended use is to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. 
CODE
H530001, H530075, H530439, H533043, H535023, H535082, H535128, H535180, H535220, H530004, H530078, H531008, H534004, H535024, H535084, H535131, H535181, H535867, H530008, H530082, H531010, H534015, H535025, H535085, H535133, H535182, H536005, H530012, H530084, H531020, H534020, H535030, H535086, H535135, H535183, H536452, H530014, H530085, H531025, H534021, H535031, H535087, H535137, H535184, H536465, H530018, H530087, H531029, H534022, H535033, H535088, H535141, H535186, H536479, H530021, H530104, H531033, H534026, H535035, H535091, H535142, H535188, H530022, H530204, H531035, H534032, H535036, H535094, H535144, H535190, H530023, H530231, H531038, H534036, H535039, H535098, H535147, H535191, H530024, H530250, H531041, H534040, H535043, H535099, H535149, H535192, H530030, H530311, H531043, H534223, H535044, H535100, H535151, H535193, H530034, H530323, H531044, H535003, H535045, H535104, H535154, H535194, H530035, H530339, H532005, H535004, H535046, H535105, H535157, H535195, H530036, H530340, H532006, H535005, H535047, H535106, H535159, H535197, H530045, H530396, H532014, H535008, H535053, H535108, H535161, H535199, H530046, H530401, H532021, H535009, H535054, H535109, H535162, H535200, H530049, H530405, H532027, H535012, H535055, H535111, H535164, H535201, H530050, H530417, H533004, H535013, H535056, H535115, H535166, H535207, H530051, H530423, H533008, H535014, H535058, H535116, H535167, H535209, H530055, H530425, H533014, H535015, H535068, H535117, H535168, H535211, H530057, H530427, H533027, H535016, H535070, H535120, H535169, H535213, H530063, H530428, H533028, H535017, H535072, H535121, H535173, H535214, H530064, H530429, H533029, H535018, H535073, H535122, H535176, H535215, H530066, H530430, H533036, H535020, H535076, H535123, H535177, H535218, H530068, H530433, H533037, H535021, H535081, H535124, H535178, H535219
RECALLING FIRM/MANUFACTURER Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, 
REASON Failure to retract or park the Varian MLC leaves prior to use of the demountable BrainLAB m3 could result in the Varian MLC leaves interfering with the treatment field defined by the BrainLAB m3 without an interlock being asserted.
VOLUME OF PRODUCT IN COMMERCE 205 units
DISTRIBUTION Nationwide and Internationally

 

PRODUCT VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit 24. For in vitro diagnostics use only. VITROS Chemistry Products Calibrator Kit 24 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of albumin in urine. Ortho-Clinical Diagnostics Inc. 
CODE Kit Lot 2430 (exp. 11/16/11), Kit Lot 2440 (exp. 01/08/12), Kit Lot 2450 (03/09/12), Kit Lot 2471 (exp. 7/14/12)
RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Rochester, NY
REASON Ortho Clinical Diagnostics received numerous complaints of lower than expected results for control fluids and patient samples upon initial calibration or following a recalibration using VITROS Chemistry Products Calibrator Kit 24 and VITROS Chemistry Products mALB Reagent.
VOLUME OF PRODUCT IN COMMERCE 4436 units worldwide (nationwide - 2201; internationally - 2235)
DISTRIBUTION Nationwide and Internationally

 

PRODUCT Volcano pcFM Software Kit. The volcano pcFM Software Kit is a research only off line tool intended for review and printout of physiological measurements recorded by ComboMap System. It is not intended for analysis or manipulation of the original measurement data. Model 6830 ComboMap Software kit; Kit. 
CODE P/N #'s: 803259001; 806431005; S2000061; 806431002
RECALLING FIRM/MANUFACTURER Volcano Corp., Rancho Cordova, CA,
REASON Internal review of validation of pcMF Software kit found that instructions directs user to remove the rear panel, causing the potential for electric shock.
VOLUME OF PRODUCT IN COMMERCE 8 units
DISTRIBUTION Nationwide, The Netherlands, Sweden and United Kingdom

 

PRODUCT Custom surgical kits: DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.02, STERILE EO, surgical kits 
CODE Lot Number 24579045 REF 89-7639.01 - Lot Number 24664258 REF 89-7639.02 - Lot Numbers: 24828048, 25598985, 25359212, 25399676
RECALLING FIRM/MANUFACTURER DeRoyal Processing Center, New Tazewell, TN,
REASON The firm distributed surgical kits which contained DermaHook Neuro Elastic Retractors which were subsequently recalled by Teleflex.
VOLUME OF PRODUCT IN COMMERCE 214 units
DISTRIBUTION Nationwide

 

PRODUCT Surgical lighting systems iLED and TruLight in use with the ALC+ function. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light
CODE Material number 1583966
RECALLING FIRM/MANUFACTURER
Recalling Firm: Trumpf Medical Systems, Inc., Charleston, SC, .
Manufacturer: Kreuzer Gmbh & Co. KG, Puchheim, Germany.
REASON The ALC+ function may not be properly locked during use resulting in the possibility of the handle falling off into the surgical field causing injury to the patient.
VOLUME OF PRODUCT IN COMMERCE 8733 units (4709 US)
DISTRIBUTION Nationwide and Internationally
 
PRODUCT New Label: EtchMaster ***Cordless Handpiece***P/N 797 HAZARD WARNING: Using CO2 cartridges from other suppliers may cause an operational hazard and will void the warrantee. Old Label: EtchMaster***Cordless Handpiece*** The Cordless Etcher air brush is powered by CO2 mini-cartridges to deliver pressurized gas to the EtchMaster pre-filled disposable micro air abrasive tips. The Cordless Etcher handpiece is quickly re-loaded with a CO2 mini-cartridge. Each CO2 mini-cartridge provides sufficient power to run 3 EtchMaster tips. The EtchMaster tips are used to abrade tooth surfaces and prosthetic devices prior to bonding procedures. 
CODE
GRO-SK-EM-CE-R-RB-Sk GRO-SK-EM-CE-K-RB-SK GRO-SK-EM-CE-K-CA-SK ROPI-EM
RECALLING FIRM/MANUFACTURER Groman Inc., Margate, FL, 
REASON When non-conforming cartridges are inserted into the Cordless Etcher they can induce excessive stresses on the device causing cracks in the plastic housing of the device. These crack can lead to a hazardous situation due to the high pressure of the gas contained in the CO2 cartridges.
VOLUME OF PRODUCT IN COMMERCE 395 devices
DISTRIBUTION Nationwide, and Netherlands

 

PRODUCT Imalux Niris OCT Imaging System Probe, Model Number 1300. The Niris Imaging System probe is used with the Niris Imaging System. The Niris Imaging System employs Optical Coherence Tomography (OCT), which can be used to construct high spatial resolution. The probe, is attached to the Imaging Console, and is used to direct light to and from the patient tissue. A small electromechanical scanning mechanism in the probe moves the optical beam laterally across the tissue surface while simultaneously acquiring in-depth backscattering profile at each lateral position. The probe is not labeled or sold as sterile. 
CODE Serial Number F464019
RECALLING FIRM/MANUFACTURER Imalux Corp., Cleveland, OH, 
REASON During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

 

PRODUCT Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors. MPM, CAMO1, PAC1. 
CODE
MEF1100103; MED1102303; MEB1101602; MEF1100203; MEC1100602; MED1101003; MED1102203; MEE1102003; MED1102103; MEC1102302; MEB1101402; MEE1101003; MEF1100703; MEE1101903; MEF1101103; MEB1100803; MEC1103002; MEE1100903; MED1101703; MED1101203; MEC1102902; MEB1101103; MEC1102002; MEB1101502; MED1102203; MEF1100603; MEE1101203; MEC1100102; MEE1101503; MEE1100703; MEF1100403; MED1101303; MED1101403; MEF1100303; MEC1100702; MED1101103; MEC1102402; MEC1101602; MEF1100903; MEE1101303; MED1102003; MEC1103302; MEE1101803; MEE1100803; MEF1100503; MEC1102502; MEC1101702; MEE1101403; MEC1103402; MEF1100803; MEC1102802; MEC1101802; MEF1101003; MEC1103102; MEC1101902; MEC1102102
RECALLING FIRM/MANUFACTURER Integra LifeSciences Corp., Plainsboro, NJ,
REASON Some of the connector cables associated with Integra's intracerebral pressure (ICP) monitors may cause temporary interference with the ICP waveform on the monitor display.
VOLUME OF PRODUCT IN COMMERCE 221 units
DISTRIBUTION Nationwide and Internationally

Flight Medical Innovations Ltd. Provides Update on Recall of Ventilator Remote Alarm Cable

Flight Medical Innovations Ltd. (Flight Medical) issued the following update regarding its recall of remote alarm cable, part number V24-00400-29, used to connect a Newport HT50 mechanical ventilator to a nurse station.  The recalled cable may negatively affect Newport HT50 ventilators manufactured prior to 2007.  Affected units may shutdown unexpectedly. 

Flight Medical initiated the recall in August 2011, which affected 363 cables.  The affected devices were distributed between April 25, 2007 and July 6, 2011.  A total of 328 cables were distributed within the US.  An additional 22 cables were distributed outside the US.  13 cables remained in the distributor’s warehouse.

Customers, including Newport Medical are requested to dispose of the affected cables properly

Customer inquiries related to this action should be addressed to Newport’s Technical Service Group at (800) 451-3111, extension 500.

WEEK ENDING FEBRUARY 11

PRODUCT Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size small and Medium, Product Code PHM912, Lot No. 002-E1LF302-1, Manufacture date JUL 2011, Size Small Product Code PHM915, Lot No. 002-E1LF305-1, Manufacture date JUL 2011, Size Medium Examination Disposable Gloves. 
CODE Lot No. 002-E1LF302-1 and Lot No. 002-E1LF305-1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Adenna Inc., Ontario, CA, 
Manufacturer: Tekmedic Sdn Bhd, Melaka, Malaysia. 
REASON The recall was initiated because Adenna Inc. distributed latex gloves that have been FDA refused.
VOLUME OF PRODUCT IN COMMERCE 427 cartons
DISTRIBUTION Nationwide

 

PRODUCT Fresenius Optiflux F250NRe Hemodialyzer, , intended for single use in acute and chronic hemodialysis Catalog No. 0500325E The Fresenius Optiflux F250NRe Hemodialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. 
CODE
Lot Codes: 8SU203 EXPIRATION DATE: 12/31/2011, 8SU204 EXPIRATION DATE: 12/31/2011, 8SU205 EXPIRATION DATE: 12/31/2011, 09DU02013 EXPIRATION DATE: 04/30/2012, 09DU02014 EXPIRATION DATE: 04/30/2012, 09DU02022 EXPIRATION DATE: 04/30/2012, 09NU02011 EXPIRATION DATE: 10/31/2012, 09PU02011 EXPIRATION DATE: 11/30/2012, 09SU02001 EXPIRATION DATE: 12/31/2012, 09SU02007 EXPIRATION DATE: 12/31/2012, 10AU02013 EXPIRATION DATE: 01/31/2013, 10CU02001 EXPIRATION DATE: 03/31/2013, 10EU02010 EXPIRATION DATE: 05/31/2013, 10EU02017 EXPIRATION DATE: 05/31/2013, 10HU02013 EXPIRATION DATE: 06/30/2013, 10HU02014 EXPIRATION DATE: 06/30/2013, 10LU02001 EXPIRATION DATE: 09/30/2013, 10LU02013 EXPIRATION DATE: 09/30/2013, 10LU02014 EXPIRATION DATE: 09/30/2013, 10LU02015 EXPIRATION DATE: 09/30/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresenius Medical Care Holdings, Inc., Waltham MA, 
Manufacturer: Fresenius Medical Care, North America, Ogden, UT. 
REASON Optiflux F250NRe Hemodialyzers have increased risk of an internal blood leak.
VOLUME OF PRODUCT IN COMMERCE 599,436 units
DISTRIBUTION Nationwide and Canada

 

PRODUCT STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. 
CODE Serial Numbers: 400000 through 405499
RECALLING FIRM/MANUFACTURER Steris Corporation Hopkins Facility, Mentor, OH, 
REASON Software deficiency. STERIS identified that water specifications were not being met at some of their customer sites. Critical parameters for initiating cycles are: water quality, water pressure and water temperature. Failure to meet these criteria may lead to cycle aborts by the SYSTEM 1E Liquid Chemical Sterilant Processing System. The firm intends to perform a software field correction which will enable the SYSTEM 1E to handle a wider range of user facility water characteristics.
VOLUME OF PRODUCT IN COMMERCE 3,882 units
DISTRIBUTION Nationwide, and Bahrain, Hong Kong, Japan and South Korea

 

PRODUCT
1) Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; The kit catalog numbers: PBVFLCAVJ, PCW1VPMUW, PE41TP55A, PE73EALUO, PE73MNLUM, PEDKEASTH, PEOCMEBL1, PEOCMEBLD, PEVFBHAVK, PEVFENAVH, PEVFHNAVJ, PEVNMJCHF, PG73HNLUL, PG73OTALUN, PGCGOTUI8, PGCGOTUII, PGVFGMAVM, PGVFLPAVC, PGVFMNAVG, PGVFOTAVD, PGVFTTAVK, PGVNGSCHJ, PLVFOTAVJ, PN21CYBIG, PN21CYBIH, PN41CY557, PN73CR11F, PN73SPLUT, PN73VPLUV, PNV2ALCPA, PNV2CY10Z, PNV2LM10R, PNV2OT10H, PNV2OTA10Q, PNVFLNAVK, PO73AALU1, PO73AALUR, PP69OHMLO, PUOCOT13J, PVV2CA10B, SBA13KDBSY, SBA23KTNCC, SBA23OPNCC, SBACGSTAHA, SCV11CACPR, SCV19OHCHX, SCV23MJNCH, SEN41TYCMC, SID21ACUHA, SIDCGISAUA, SNE11ALCPA, SNE11CR10F, SNE11LM10C, SNE11NMCPX, SNE14ACHHK, SNE14CRHHK, SNE14LLHHN, SNE21SHEGS, and SNE32CRSA7 contain one or more of the following listed components: a) Silastic Tubing, 0.062 ID x 0.032 Wall x 50 Ft, component C-602-285, vendor part number SFM3-2850; b) Silastic Tubing, 0.040 ID x 0.023 Wall x 50 Ft, component C-SFM3-2050, vendor part number SFM3-2050; c) Pathology Container with Lid, 8 oz., component 3701Z, vendor part number 3701; d) Silicone Tubing, 0.187 ID x 0.313 OD x 50 Ft., component C-31010SG, vendor part number 31010;
 
2) Presource Custom Sterile Surgical and Procedure Kits; surgical trays; The kit catalog numbers kit catalog numbers ICU955327G, ICU955327H, and MAT330041C contain one or more of the following listed components: a) Cool Peri-Pad Self-Adhesive Absorbent Pad with Built-In Cold Pack, component C-CP23, vendor part number CP23; b) Giraffe Disposable Skin Temperature Probe, vendor part number 6600-0873-700. 
CODE 1) and 2) All recent lots
RECALLING FIRM/MANUFACTURER Cardinal Health, McGaw Park, IL,
REASON Some of the components contained in the Presource kits are being recalled because Cardinal Health has determined that the component manufacturer(s) does not have all necessary FDA registrations or filings needed for this product
VOLUME OF PRODUCT IN COMMERCE 7,213 each
DISTRIBUTION Nationwide

 

PRODUCT Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy system sets. --- Stand alone labeling: Vision Sciences Battery Charger, Lithium Ion [REF] 07-3051; [MFG Symbol. Accessory to endoscopy kits used to charge/recharge lithium ion batteries. Products which include this item are VISION SCIENCES CAT. No. ITEM Description; 07-3051 Battery Charger, Lithium-Ion; 07-3051X Battery Charger, Lithium-Ion*; 07-3053 BLS Kit; 07-3053X BLS Kit*; 07-3052 Rechargeable Batteries, Lithium-Ion; 07-3052X Rechargeable Batteries, Lithium-Ion*; 02-2602 ENT-3000 Scope (Standard Set); 02-2602-IN ENT-3000 Scope (Standard Set)*; 02-2602X ENT-3000 Scope (Standard Set)*; 02-4201 ENT-4000 Portable Set; 02-4201X ENT-4000 Portable Set. 
 
Product is a lithium ion battery sold as both a stand-alone accessory, and as part of endoscopy system sets. Stand alone labeling: Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2) [REF] 07-3052; [MFG Symbol] Accessory to endoscopy kits used to charge/recharge lithium ion batteries. Products which include this item are VISION SCIENCES CAT. No. ITEM Description; 07-3051 Battery Charger, Lithium-Ion; 07-3051X Battery Charger, Lithium-Ion*; 07-3053 BLS Kit; 07-3053X BLS Kit*; 07-3052 Rechargeable Batteries, Lithium-Ion; 07-3052X Rechargeable Batteries, Lithium-Ion*; 02-2602 ENT-3000 Scope (Standard Set); 02-2602-IN ENT-3000 Scope (Standard Set)*; 02-2602X ENT-3000 Scope (Standard Set)*; 02-4201 ENT-4000 Portable Set; 02-4201X ENT-4000 Portable Set. 
CODE All units
RECALLING FIRM/MANUFACTURER Vision-Sciences, Inc. Orangeburg, NY,
REASON Potential for over-heating and possible burning of the lithium-ion batteries being charged.
VOLUME OF PRODUCT IN COMMERCE 1618 chargers, 3628 batteries
DISTRIBUTION Nationwide and Internationally

 

PRODUCT KIMBERLY CLARK MIC GASTRO-ENTERIC FEEDING TUBE, 22F. Gastro-Enteric Feeding Tube. Catalogue number: 0210-22. 
CODE Lot number: AA1129E02
RECALLING FIRM/MANUFACTURER

Recalling Firm: Kimberly-Clark Corp., Roswell, GA, 

Manufacturer: Avent S.A. De C.V, Nogales Sonora, Mexico. 

REASON The product is misbranded, i.e. the Gastric (center) port may be mislabeled as the Jejunal port, and the Jejunal (side) port mislabeled as the Gastric port.
VOLUME OF PRODUCT IN COMMERCE 50 devices
DISTRIBUTION Nationwide and Canada

 

PRODUCT DRAD-3000E: Radrex-i X-Ray is a general purpose X-ray System. Labeling reads in part "TOSHIBA***DIGITAL RADIOGRAPHY SYSTEM RADREX-i DRAD-3000E Systems Data No. MSDXR0144EA***" 
CODE
Serial numbers of the following: U2A0892009, U2A08X2010, U2A08X2011, U2A08Y2012, U2A08Z2013, U2A08Z2014, U2A0912015, U2A0912016, U2A0922017, U2A0942019, U2A0942020, U2A0942021, U2A0952022, U2A0952023, U2A0972024, U2A0972025, U2A0982026, U2B09X2027, U2B09Y2028, U2B09Y2029, U2B09Z2030, U2B1042031, U2B1042032, U2C1052033, U2C1062034, U4A0982001, U4A0982002, U4A0992003, U4A09X2004, U4A09Z2005, U4A09Z2006, U4A09Z2007, U4A1022009, U4B1022010, U4B1032011, U4B1052012, U4B1052013, U4B1062014, U6A0972001 and U4B1012008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA,
REASON It has been found that some of the starter cables used for x-ray tube high speed rotation are not sufficiently durable.
VOLUME OF PRODUCT IN COMMERCE 39 units
DISTRIBUTION Nationwide

 

PRODUCT Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic. 
CODE ROM versions prior to 3.40
RECALLING FIRM/MANUFACTURER Alere San Diego, San Diego, CA, 
REASON Alere has identified that a bias on results for certain analytes tested on the Alere Cholestech LDX System may exist due to humidity variability.
VOLUME OF PRODUCT IN COMMERCE 22,000 meters
DISTRIBUTION Nationwide and Internationally

North American Rescue, LLC Announces A Recall of Crickit® Convenience Kits  

North American Rescue, LLC (NAR) announces the recall of the NAR Surgical Crichothyroidotomy Kit or Crickit®, due to potential contamination of the povidone iodine prep pads, manufactured by Triad Group. 

The Crickit® Kit component may be found inside a larger kit, the NAR Medic Trauma Pack Kits, available in 4 colors for which the codes are listed below. Only the Crickit® component is being recalled. Please see the attached lot numbers for the affected Crickit® Kits. The affected lot numbers for the Medic Trauma Pack Kits can be found on the North American Rescue website www.narescue.com. Please note that this product has been discontinued and therefore is no longer included in the Medic Trauma Pack Kits.

Product Code Item Description Lot Numbers
10-0017 Surgical Cricothyroidotomy Kit or Crickit®  
80-0070 Medic Trauma Pack Kit – BLK (Black)  
80-0071 Medic Trauma Pack Kit – ODG (Green)  
80-0072 Medic Trauma Pack Kit – COY (Tan)  
80-0096 Medic Trauma Pack Kit – DUC (Camouflage)  

Customers are instructed to immediately discontinue the use of the Crickit® convenience kits and to contact North American Rescue Customer Service for instructions for returning the product. Only the Crickit® should be returned from the Medic Trauma Pack Kits.

Consumers with questions may contact North American Rescue at 1-888-689-6277, Monday through Friday, 8:00am to 5:00pm (ET).
Part Number: 10-0017    Description: Crickit or Surgical Cricothyroidotomy Kit

Lot #
21096
21420
21421
21422
21423
21424
21910
21911
21912
21913
22151
22152
22289
22290
22344
22345
22346
22347
22725
22726
22727
22728
22946
22947
22948
22949

 WEEK ENDING FEBRUARY 4

 PRODUCT Syngo Imaging XS, all versions Radiological image processing system. Model number 10496279.
CODE None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA,
Manufacturer: Siemens AG, Medical Solutions, Business Unit XP, Erlangen, Germany.
REASON The "Rename" functionality can cause an unintended patient merge if the renamed patient is sent to another system.
VOLUME OF PRODUCT IN COMMERCE 38
DISTRIBUTION Nationwide

 

PRODUCT VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate the VITROS 5, 1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of rheumatoid factor (RF).
CODE Lot #: 1630
RECALLING FIRM/MANUFACTURE Ortho-Clinical Diagnostics, Rochester, NY,
REASON Product will not likely meet its specified 12 months of stability.
VOLUME OF PRODUCT IN COMMERCE 768 kits
DISTRIBUTION Nationwide, Internationally

 

PRODUCT Tobramycin Calibrators, REF 7F93-01; Tobramycin is a commonly used antibiotic to treat bacterial infections, in particular gram negative infections.
CODE Lots: 59281991, Exp 11-30-11, 59359468, Exp 2-29-12, 59590335, Exp 6-30-12, 59511648, Exp 8-31-12
RECALLING FIRM/MANUFACTURER Microgenics Corp., Fremont, CA,
REASON Reports that third party control material for 4 lots of Tobramycin Calibrators that are recovering low and outside of the published range.
VOLUME OF PRODUCT IN COMMERCE 1,366 kits
DISTRIBUTION Nationwide and Europe

 

PRODUCT Leo 3-Wheel Scooter and Leo Scooter, Model # LEO-4B; Intended to provide transportation for a disabled or elderly person.
CODE
Serial # 10MCT000110, 10MCT000111, 10MCT000112, 10MCT000113, 10MCT000114, 10MCT000115, 10MCT000116, 10MCT000117, 10MCT000118, 10MCT000119, 10MCT000120, 10MCT000121, 10MCT000122, 10MCT000123, 10MCT000124, 10MCT000125, 10MCT000126, 10MCT000127, 10MCT000128, 10MCT000129, 10MCT000130, 10MCT000131, 10MCT000132, 10MCT000133, 10MCT000134, 10MCT000135, 10MCT000136, 10MCT000137, 10MCT000138, 10MCT000139, 10MCT000140, 10MCT000141, 10MCT000142, 10MCT000143, 10MCT000144, 10MCT000145, 10MCT000146, 10MCT000147, 10MCT000148, 10MCT000149, 10MCT000150, 10MCT000151, 10MCT000152, 10MCT000153, 10MCT000154, 10MCT000155 & 10MCT000156. Model # LEO-4S; Serial # 10MCT000001, 10MCT000002, 10MCT000003, 10MCT000004, 10MCT000005, 10MCT000006, 10MCT000007, 10MCT000008, 10MCT000009, 10MCT000010, 10MCT000011, 10MCT000012, 10MCT000013, 10MCT000014, 10MCT000015, 10MCT000016, 10MCT000017, 10MCT000018, 10MCT000019, 10MCT000020, 10MCT000021, 10MCT000022, 10MCT000023, 10MCT000024, 10MCT000025, 10MCT000026, 10MCT000027, 10MCT000028, 10MCT000029, 10MCT000030, 10MCT000031, 10MCT000032, 10MCT000033, 10MCT000034, 10MCT000035, 10MCT000036, 10MCT000037, 10MCT000038, 10MCT000039, 10MCT000040, 10MCT000041, 10MCT000042, 10MCT000043, 10MCT000044, 10MCT000045, 10MCT000046, 10MCT000047, 10MCT000048, 10MCT000049, 10MCT000050, 10MCT000051, 10MCT000052, 10MCT000053, 10MCT000054, 10MCT000055, 10MCT000056, 10MCT000057, 10MCT000058, 10MCT000059, 10MCT000060, 10MCT000061, 10MCT000062, 10MCT000063, 10MCT000064, 10MCT000065, 10MCT000066, 10MCT000067, 10MCT000068, 10MCT000069, 10MCT000070, 10MCT000071, 10MCT000072, 10MCT000073, 10MCT000074, 10MCT000075, 10MCT000076, 10MCT000077, 10MCT000078, 10MCT000079, 10MCT000080, 10MCT000081, 10MCT000082, 10MCT000083, 10MCT000084, 10MCT000085, 10MCT000086, 10MCT000087, 10MCT000088, 10MCT000089, 10MCT000090, 10MCT000091, 10MCT000092, 10MCT000093, 10MCT000094, 10MCT000095, 10MCT000096, 10MCT000097, 10MCT000098, 10MCT000099, 10MCT000100, 10MCT000101, 10MCT000102, 10MCT000103, 10MCT000104, 10MCT000105, 10MCT000106, 10MCT000107, 10MCT000108, 10MCT000109, 10MDG0001, 10MDG0002, 10MDG0003, 10MDG0004, 10MDG0005, 10MDG0006, 10MDG0007, 10MDG0008, 10MDG0009, 10MDG0010, 10MDG0011, 10MDG0012, 10MDG0013, 10MDG0014, 10MDG0015, 10MDG0016, 10MDG0017, 10MDG0018, 10MDG0019, 10MDG0020, 10MDG0021, 10MDG0022, 10MDG0023, 10MDG0024, 10MDG0025, 10MDG0026, 10MDG0027, 10MDG0028, 10MDG0029, 10MDG0030, 10MDG0047, 10MDG0048, 10MDG0049, 10MDG0050, 10MDG0051, 10MDG0052, 10MDG0053, 10MDG0054, 10MDG0055, 10MDG0056, 10MDG0057, 10MDG0058, 10MDG0059, 10MDG0060, 10MDG0061, 10MDG0062, 10MDG0063, 10MDG0064, 10MDG0065, 10MDG0066, 10MDG0067, 10MDG0068, 10MDG0069, 10MDG0070, 10MDG0071, 10MDG0072, 10MDG0073, 10MDG0074, 10MDG0075, 10MDG0076, 10MDG0077, 10MDG0078, 10MDG0079, 10MDG0080, 10MDG0081, 10MDG0082, 10MDG0083, 10MDG0084, 10MDG0085, 10MDG0086, 10MDG0087, 10MDG0088, 10MDG0089, 10MDG0090, 10MDG0091, 10MDG0092, 10MDG0093, 10MDG0094, 10MDG0095, 10MDG0096, 10MDG0097, 10MDG0098, 10MDG0099, 10MDG0100, 10MDG0101, 10MDG0102, 10MDG0103, 10MDG0104, 10MDG0105, 10MDG0106, 10MDG0107, 10MDG0108, 10MDG0109, 10MDG0110, 10MDG0111, 10MDG0112, 10MDG0113, 10MDG0114, 10MDG0115, 10MDG0116, 10MDG0117, 10MDG0118, 10MDG0119, 10MDG0120, 10MDG0121, 10MDG0122, 10MDG0123, 10MDG0124, 10MDG0125, 10MDG0126, 10MDG0127, 10MDG0128, 10MDG0129, 10MDG0130, 10MDG0131, 10MDG0132, 10MDG0133, 10MDG0134, 10MDG0135, 10MDG0151, 10MDG0152, 10MDG0153, 10MDG0154, 10MDG0155, 10MDG0156, 10MDG0157, 10MDG0158, 10MDG0159, 10MDG0160, 10MDG0161, 10MDG0162, 10MDG0163, 10MDG0164, 10MDG0165, 10MDG0166, 10MDG0167, 10MDG0168, 10MDG0169, 10MDG0170, 10MDG0171, 11ADG0001, 11ADG0002, 11ADG0003, 11ADG0004, 11ADG0005, 11ADG0006, 11ADG0007, 11ADG0008, 11ADG0009, 11ADG0010, 11ADG0011, 11ADG0012, 11ADG0013, 11ADG0014, 11ADG0015, 11ADG0016, 11ADG0017, 11ADG0018, 11ADG0019, 11ADG0020, 11ADG0021, 11ADG0022, 11ADG0023, 11ADG0024, 11ADG0025, 11ADG0026, 11ADG0027, 11ADG0028, 11ADG0029, 11ADG0030, 11ADG0031, 11ADG0032, 11ADG0033, 11ADG0034, 11ADG0035, 11ADG0036, 11ADG0037, 11ADG0038, 11ADG0039, 11ADG0040, 11ADG0041, 11ADG0042, 11ADG0073, 11ADG0074, 11ADG0075, 11ADG0076, 11ADG0077, 11ADG0078, 11ADG0079, 11ADG0080, 11ADG0081, 11ADG0082, 11ADG0083, 11ADG0084, 11ADG0085, 11ADG0086, 11ADG0087, 11ADG0088, 11ADG0089, 11ADG0090, 11ADG0091, 11ADG0092, 11ADG0093, 11ADG0094, 11ADG0095, 11ADG0096, 11ADG0097, 11ADG0098, 11ADG0099, 11ADG0100, 11ADG0101, 11ADG0102, 11ADG0103, 11ADG0104, 11ADG0105, 11ADG0106, 11ADG0107, 11ADG0108, 11ADG0109, 11ADG0110, 11ADG0111, 11ADG0112, 11ADG0113, 11ADG0114, 11ADG0115, 11ADG0116, 11ADG0117, 11ADG0118, 11ADG0119, 11ADG0120, 11ADG0121, 11ADG0122, 11ADG0123, 11ADG0124, 11ADG0125, 11ADG0126, 11ADG0127, 11ADG0128, 11ADG0129, 11ADG0130, 11ADG0131, 11ADG0132, 11ADG0133, 11ADG0134, 11ADG0135, 11ADG0136, 11ADG0137, 11ADG0138, 11ADG0139, 11ADG0140, 11ADG0141 & 11ADG0142
RECALLING FIRM/MANUFACTURE
Recalling Firm: Invacare Corp., Elyria, OH,  
Manufacturer: Chien Ti Enterprise Co., Ltd., Hsin Chuang, Taipei, Taiwan. .
REASON The scooter backrest fails unexpectedly due to seat flexing, and this has the potential to result in a consumer falling causing death or serious injury.
VOLUME OF PRODUCT IN COMMERCE 391 scooters
DISTRIBUTION Nationwide and Internationally

 

PRODUCT CADD High Volume Administration Set, REF 21-7081V-01, Sterile EO, Rx only. Designed for use with CADD pumps to allow fluid delivery from an IV bag.
CODE Lot #: 21X222
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smiths Medical ASD, Inc., Saint Paul, MN, 
Manufacturer: Smiths Healthcare Manufacturing S.A. de C.V., Tijuana, B.C., Mexico.
REASON Smith Medical has become aware of a small number of customer reports regarding occlusions/high pressure alarms with the use of one lot of CADD High Volume Administration Sets.
VOLUME OF PRODUCT IN COMMERCE 5,385 units
DISTRIBUTION Nationwide

 

PRODUCT Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457.
CODE Serial #’s: 100174, 100177, and 100181
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA,.
Manufacturer: Siemens AG, Medical Solutions, Business Unit XP, Erlangen, Germany. .
REASON The firm has become aware of the potential for an unintended merge of multiple patients when using syngo.plaza version VA20 with Server Farm setup integrated to a RIS. Sporadically it can happen that certain Patient IDs in the database are deleted and sent to NULL. This can cause incorrect merging with patients that already had a NULL Patient ID.
VOLUME OF PRODUCT IN COMMERCE 3
DISTRIBUTION Nationwide

 

PRODUCT Surgical Headlight labeled in part * Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, and GMF-H106. The Surgical Headlight is a passive luminaire. It is illuminated by a source of light by way of the fiber optics and provides supplemental lighting for medical and surgical procedures.
CODE None
RECALLING FIRM/MANUFACTURER Gulf Medical Fiberoptics, Inc., Oldsmar, FL
REASON The cleaning instructions for the exterior surfaces of the headlight, headgear and fiber cable with 70% isopropyl alcohol had not been validated.
VOLUME OF PRODUCT IN COMMERCE 381
DISTRIBUTION Nationwide and Internationally

 

PRODUCT GE LOGIQ P6 Ultrasound System. The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications of: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and intraoperative (abdominal, thoracic, vascular and neurological).
CODE
Serial Number 144435SU5 133455SU6 140253SU6 140402SU9 143461SU2 135592SU4 135919SU9 143853SU0 143854SU8 143855SU5 143856SU3 143857SU1 143858SU9 144424SU9 136031SU2 137467SU7 138561SU6 140683SU4 144432SU2 144436SU3 144444SU7 144425SU6 144427SU2 144428SU0 144429SU8 144921SU4 146150SU8 146151SU6 146152SU4 146153SU2 146155SU7 146156SU5 146157SU3 146158SU1 146159SU9 146160SU7 146161SU5 146165SU6 146166SU4 146167SU2 146168SU0 146169SU8 146171SU4 146174SU8 148045SU8 148046SU6 148047SU4 148048SU2 148049SU0 148233SU0 148234SU8 148235SU5 148238SU9 148964SU0 148965SU7 148966SU5 148967SU3 149150SU5 149152SU1 149153SU9 149720SU5 149721SU3 149722SU1 149723SU9 150499SU2 150500SU7 150501SU5 151265SU6 151270SU6 151271SU4 151272SU2 151273SU0 151274SU8 151275SU5 151276SU3 151972SU7 151973SU5 151974SU3 151975SU0 151976SU8 151977SU6 151978SU4 151979SU2 151980SU0 152623SU5 152624SU3 152625SU0 152626SU8 153218SU3 153219SU1 153220SU9 153221SU7 153222SU5 153223SU3 153224SU1 153483SU3 153484SU1 153485SU8 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155266SU0 155267SU8 155268SU6 155646SU3 155650SU5 155652SU1 155654SU7 155655SU4 155656SU2 155657SU0 155658SU8 155659SU6 155660SU4 155861SU8 155862SU6 155863SU4 155866SU7 155867SU5 155869SU1 155870SU9 155873SU3 155874SU1 155875SU8 155877SU4 155878SU2 155882SU4 155885SU7 155887SU3 155888SU1 155889SU9 155890SU7 155892SU3 155893SU1 156010SU1 156114SU1 156115SU8 156116SU6 156117SU4 156118SU2 156331SU1 156625SU6 156626SU4 156627SU2 156628SU0 156631SU4 156632SU2 156633SU0 156634SU8 156635SU5 156636SU3 156637SU1 156638SU9 156639SU7 156652SU0 156796SU5 156797SU3 156798SU1 156799SU9 157124SU9 157177SU7 157199SU1 157209SU8 157210SU6 157403SU7 157404SU4 157447SU4 157448SU2 157451SU6 157704SU8 157705SU5 157706SU3 157707SU1 157708SU9 157709SU7 157710SU5 157711SU3 158098SU4 158099SU2 158100SU8 158101SU6 158277SU4 158356SU6 158357SU4 158358SU2 158359SU0 158360SU8 158361SU6 158362SU4 158363SU2 158364SU0 158365SU7 158366SU5 158369SU9 158370SU7 158668SU4 158669SU2 158670SU0 158671SU8 158672SU6 158673SU4 158674SU2 158675SU9 158676SU7 158677SU5 158678SU3 158679SU1 158680SU9 158686SU6 158687SU4 158688SU2 158689SU0 158690SU8 158691SU6 158692SU4 158693SU2 158694SU0 158695SU7 158696SU5 158697SU3 158698SU1 158699SU9 158700SU5 158701SU3 158702SU1 158703SU9 158704SU7 158705SU4 158706SU2 158707SU0 158708SU8 158709SU6 158710SU4 158711SU2 158712SU0 158713SU8 158714SU6 158715SU3 158717SU9 158718SU7 159075SU1 159076SU9 159077SU7 159078SU5 159079SU3 159080SU1 159081SU9 159082SU7 159083SU5 159084SU3 159086SU8 159088SU4 159092SU6 159238SU5 159267SU4 159268SU2 159269SU0 159270SU8 159271SU6 159626SU1 159814SU3 159815SU0 159996SU8 160526SU0 161521SU0 161522SU8 161527SU7 161537SU6 161539SU2 162044SU2 162048SU3 162516SU9 162529SU2  
RECALLING FIRM/MANUFACTURE
Recalling Firm: GE Healthcare, LLC, Waukesha, WI,   
Manufacturer: GE Ultrasound Korea Co., Ltd., Kyunggi-Do Korea, Republic Of (South).
REASON GE Logic P6 probe head has a possibility to cause burn injuries to patients or operators.
VOLUME OF PRODUCT IN COMMERCE 2,270
DISTRIBUTION Nationwide and Internationally

 

PRODUCT
1) Roller Pump, 4 Inch Diameter The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog Number 816570.
 
2) Roller Pump, 6 Inch Diameter The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog Number 816571.
CODE
1) Serial Numbers: 5939 – 5962;
2) Serial Numbers 6621 - 6640
RECALLING FIRM/MANUFACTURE Terumo Cardiovascular Systems Corp., Ann Arbor, MI,
REASON During incoming inspection a single digital encoder cable assembly was rejected  because it had a loose wire. The assembly is used in the 4" and the 6" roller pumps for the Terumo Advanced Perfusion System 1.
VOLUME OF PRODUCT IN COMMERCE 44 units
DISTRIBUTION Nationwide, Canada, Mexico, and Vietnam

 

PRODUCT Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in vitro diagnostic use only. Intended use: Drug abuse detection. Catalog number 0803.
CODE Lot #: 1101136K3, exp 1/28/13
RECALLING FIRM/MANUFACTURER Lin-Zhi International Inc., Sunnyvale, CA,
REASON Multi Analyte Urine DAU Cutoff Calibrator Gives a decreased absorbance reading due to a loss of the BZO (oxazepam) analyte from the solution and may cause false positive readings.
VOLUME OF PRODUCT IN COMMERCE 45 items
DISTRIBUTION Nationwide and Germany

 

PRODUCT Visum LED Surgical Lights, Ceiling Mounted Surgical Light. The Visum LED surgical light is intended to illuminate the operative site during surgical procedures with high intensity light. Catalog Number: 0682001250, 0682001251, 0682001252, and 0682001253. Part Number: P10235, P10234, P12875, P12874. Product Numbers: PI0235 (Visum LED Surgical Light, Camera Ready), PI0234 (Visum LED Surgical Light), P12875 (Visum LED Surgical Light Camera Ready - Low Ceiling), PI2874 (Visum LED Surgical Light - Low Ceiling). Expiration date: There is no expiration date with the scope of the action.
CODE Serial Numbers: Product manufactured between October 20I0 to July 20II and in use by customer.
RECALLING FIRM/MANUFACTURER Stryker Communications Corp., Flower Mound, TX,
REASON Stryker became aware that there was a possibility that incorrect assembly could result in the light head beginning to separate from the suspension arm. In the event the light separates and falls from the arm, it could lead to serious injury.
VOLUME OF PRODUCT IN COMMERCE 1,143 devices
DISTRIBUTION Nationwide and Internationally

 

PRODUCT Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The intended use of this device is for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts and veneers. Additional Indications include core-buildup material, pit and fissure sealant and cementation of crown restorations to implants
CODE Lot #: 3360900
RECALLING FIRM/MANUFACTURER Kerr Corp., Orange, CA,
REASON The recall was initiated because Kerr Corporation has confirmed that the use of the affected lot of Maxcem Elite may not provide users with a minimum of 2 minutes of worktime thereby causing the product to prematurely set by 15 seconds.
VOLUME OF PRODUCT IN COMMERCE 463 units
DISTRIBUTION Nationwide Canada, Australia and New Zealand

 

PRODUCT VITROS Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD --- Common/Usual Name: VITROS DT Calibrator Kit -- VITROS Chemistry Products DT Calibrator Kit is an in vitro diagnostic specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl-, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.
CODE Kit Lot 37 (exp. 3/31/12) and Kit Lot 38 (exp. 3/31/13)
RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Rochester, NY,
REASON Negatively biased NBIL results could occur for quality control, proficiency and patient samples. As a result, VITROS Chemistry Products DT Calibrator Kit Lots 37 & 38 calibrator values were adjusted to allow customers to continue using their inventory of affected kits.
VOLUME OF PRODUCT IN COMMERCE 12,750 units
DISTRIBUTION Nationwide and Internationally

 

PRODUCT NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator, footswitch, disposable electrode. Catalog #20300101 Intended use: the generator system with six outputs is indicated for surgical ablation of soft tissue.
CODE Batch codes: 00800709, 00880909, 00870909, 00630609, 00610609, 00470109, 00080508, 00180608, 00050508, 00460109, 00830709, 00240708, 00500209, 00930909, 00430109, 00480209, 00371008, 01210911, 00650709, 00670709, 00690709, 00850909, 00920909, 00820709, 00860909, 00890909, 00940909, 00780709, 00770709, 00760709, 00910909, 00790709, 00361008, 00750709, 00510209, 00450109, 00421208, 00490209, 00530209, 00600609
RECALLING FIRM/MANUFACTURER
Recalling Firm: Angiodynamics Worldwide Headquartery S, Latham, NY, .
Manufacturer: Angiodynamics, Inc., Queensbury, NY.
REASON Angiodynamics was marketing the NanoKnife System with the ablation zone estimator feature in the US without FDA clearance.
VOLUME OF PRODUCT IN COMMERCE 40
DISTRIBUTION Nationwide

 

PRODUCT
1) The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient Use only. Use with Negative Pressure Wound Dressing. Contents: Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm x 40cm Hook Sheet. Caution: Federal Law restricts this device to sale by or on the order of a physician. Sterile: Contents are sterile for maximum two years unless enclosed package has been opened or damaged. The Wittmann Patch is used for a fascia expander prosthesis to temporarily close the abdominal cavity when regular abdominal closure is not possible; to prevent perfusion impairment of abdominal organs from increases intra-abdominal pressure; and for advanced intra-abdominal pathology requiring more than one abdominal operation to control the disease process.
 
2) The Artificial Bur HypoPack is a Temporary Fascial Prothesis with Hypobaric Wound Dressing. For Single Patient Use only. Contents: 1. Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm x 40cm Hook Sheet. 2. 60cm x 85 cm Steri Drape 3. Drain with Connector 4. 4 x Gauze Rolls Caution: Federal Law restricts this device to sale by or on the order of a physician. Sterile: Contents are sterile for maximum two years unless enclosed package has been opened or damaged. The Wittmann Patch is used for a fascia expander prosthesis to temporarily close the abdominal cavity when regular abdominal closure is not possible; to prevent perfusion impairment of abdominal organs from increases intra-abdominal pressure; and for advanced intra-abdominal pathology requiring more than one abdominal operation to control the disease process.
CODE
1) Lot #: 54643.2;
2) Lot #s: 1010.0, 1102.1, and 1103.1
RECALLING FIRM/MANUFACTURE
Recalling Firm: Novomedicus LLC, Nokomis, FL,
Manufacturer: Hidih Surgical, Doerrebach, Germany.
REASON Cytotoxicity testing revealed a biocompatibility issue. The test results did not represent a health risk.
VOLUME OF PRODUCT IN COMMERCE 47 patches and kits
DISTRIBUTION Nationwide and Internationally

 

PRODUCT MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.
CODE Lot #: F001357
RECALLING FIRM/MANUFACTURE Howmedica Osteonics Corp dba Stryker Craniomaxillofacial, Newnan, GA
REASON The template that is packaged with this implant was not packaged according to specification. The template was packaged in a single pouch instead of a double pouch.
VOLUME OF PRODUCT IN COMMERCE 10 units
DISTRIBUTION Nationwide Australia and Canada
 
PRODUCT
1) Package of cross-drive bone screws labeled in part: "***REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN***" "***REF: 91-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. ***" Products subject to recall: REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK. REF: 91-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 1/PK. Internal fixation screw intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
 
2) Package of center-drive bone screws labeled in part: "***REF: 01-7204***1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG***1.5 X4MM TITANIUM*** CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***" REF: 99-7204***"1.5MM" SYSTEM CENTER-DRIVE SCREW, 1/ PKG***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***" REF: 01-7204 1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG. REF: 99-7204 "1.5MM" SYSTEM CENTER-DRIVE SCREW, 1/ PKG. Internal fixation screw intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
CODE
1) Lot # 622120;
2) Lot # 202450
RECALLING FIRM/MANUFACTURER Biomet Microfixation, Inc., Jacksonville, FL,
REASON A possibility that these products are mixed.
VOLUME OF PRODUCT IN COMMERCE Center drive screws-484, Cross drive screws-295
DISTRIBUTION Nationwide, S Africa and Japan

 

PRODUCT Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator. The X-coated Capiox SX18 Hollow Fiber Oxygenators with Detachable Hardshell Reservoir are used to exchange gases between extracorporeal blood and a gaseous environment during cardiopulmonary bypass procedures. The integral heat exchanger is used to warm or cool the blood or perfusion fluid and the detachable hardshell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. Product code 3CXSX18RX.
CODE Lot # HF22
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Corp., Elkton, MD,
REASON Complaints were received of expired X-coated Capiox SX18 Hollow Fiber oxygenators.
VOLUME OF PRODUCT IN COMMERCE 16 units (4 cases of 4 units)
DISTRIBUTION Nationwide