OCTOBER 2014
WEEK ENDING OCTOBER 25
| Product Type | Product Description | Code Info | Classification | Reason for Recall | Recalling Firm |
|---|---|---|---|---|---|
| Devices | Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe. | Product Numbers:
ASK-04001-VCUH, ASK-04510-MM3, ASK-05001-TSC, ASK-05052-QV,
ASK-05052-SFL, ASK-05502-UWMC, ASK-05541-MS2, ASK-09804-SPH,
ASK-09810-PCMH1, ASK-09903-ECL, ASK-09903-PCMH1, ASK-11142-MGH3,
ASK-12703-MGH2, ASK-12703-SPH, ASK-15703-MH, ASK-15854-FAM,
ASK-17702-PJHH1, ASK-21142-HF2, ASK-21242-PCMH1, ASK-21242-SFM1,
ASK-21242-UVA3, ASK-29803-HF3, ASK-29803-MM, ASK-29803-MS,
ASK-29903-UK, ASK-29903-UK, ASK-34041-PTG, ASK-34052-PTG,
ASK-35052-PTG, ASK-42703-AMC, ASK-42703-OHU1, ASK-42703-PCCH1,
ASK-42703-PCSJ, ASK-42703-PPMC, ASK-42703-PSBM, ASK-42703-PSCH,
ASK-42703-PSFM, ASK-42703-PTRH, ASK-42703-SJMT, ASK-42703-UHC,
ASK-42802-ECL1, ASK-42802-PMCG, ASK-42802-PUCS, ASK-42854-CMC2,
ASK-45703-MM2, ASK-45703-NYU1, ASK-45703-PCCH1, ASK-45703-PCHS1,
... More |
Class II | Arrow International Inc. is recalling Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe because the component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and potentially product sterility. | Arrow International Inc |
| Devices | Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion. | Catalog #1806-1406S - Lot #'s K019A3C, K031467, K032811, K032812, K06AAA8, K07F95F and K083672, expiry date 3/31/2019 and Catalog #1806-1407S - Lot #'s K031468, K03E8AD and K074529, expiry date 3/31/2019 | Class II | Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label. | Stryker Howmedica Osteonics Corp. |
| Devices | Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate. | Model/Catalog/Part Number: 1. 03337103001 2. 03337111001 3. 03337154001 4. 03337138001 5. 03337120001 6. 03337146001 7. 03337111692 8. 03337138692 9. 03337154692 | Class III | The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with corresponding ranges listed in the Instructions for Use for the analyzer and the reference literature source. | Roche Diagnostics Operations, Inc. |
| Devices | Philips Expression MR200 MRI Patient Monitoring System | Model: 866120, Lot numbers: US33600004, US33600005, US33600006, US33600007, US33600008, US33600009, US33600010, US33600011, US33600012, US33600013, US33600014, US33600015, US33600016, US33600017, US33600018, US33600019, US33600020, US33600022, US33600023, US33600024, US33600025, US33600026, US33600027, US33600028. | Class II | Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement. | Invivo Corporation |
| Devices | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry 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. | Software Version 3.0 and below; Serial Numbers J46000012 - J46000456 (serial numbers are sequential; J Numbers are analogous to serial numbers) | Class II | Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden). | Ortho-Clinical Diagnostics |
| Devices | VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. | Software Version 3.0 and below; Serial Numbers J56000110 - J56001995 (serial numbers are sequential; J Numbers are analogous to serial numbers) | Class II | Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden). | Ortho-Clinical Diagnostics |
| Devices | Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R | All lots | Class I | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators | Covidien LLC |
| Devices | Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected Part Number: 22660PC | Al lot codes | Class I | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs | Covidien LLC |
| Devices | Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660 | Al lot codes | Class I | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs | Covidien LLC |
| Devices | Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006 | Al lot codes | Class I | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs | Covidien LLC |
| Devices | MediChoice® Multifunction Electrode Part Number: MC171 OH | Al lot codes | Class I | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs | Covidien LLC |
| Devices | Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A | Al lot codes | Class I | Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs | Covidien LLC |
| Devices | EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. | Part Number: PN
410322-04, -05 Serial Numbers: SH1484 SH1879 SH1875 SH1485 USG332
SH0561 USG803 SH1406 SH1405 SH0034 SH0554 SH0554 USG160 USG575 SH0908
SH2066 SH1455 SH0975 SH1475 SH1168 SH1552 SH0608 SH0608 SH1756 SH1716
USG071 USG038 SH0607 SH1590 SH1686 SH1639 SH1688 SH1740 SH1932 USG323
SH1944 USG286 SH1945 SH2022 SH2085 SH1108 SH2047 USG257 ... More |
Class II | Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System. | Intuitive Surgical, Inc. |
| Devices | EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. | EndoWrist Stapler 45 instrument, Model Number: IS3000 Part Number: PN 410298-06, -07, -08, -09 All Lots. | Class II | Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue. | Intuitive Surgical, Inc. |
| Devices | Multi-Lumen Central Venous Catheterization Kit | Catolog No - AK-12703 lot number RF3039028 | Class II | Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date. | Arrow International Inc |
| Devices | eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (including but not limited to CT,MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm Workstation can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record. | versions 4.0 and 4.0.1 | Class II | There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple studies may lead to the selection of an incorrect study. | Merge Healthcare, Inc. |
| Devices | ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine. | Lot No. 141012 | Class II | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert. | Ameditech Inc |
| Devices | ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine. | Lot No. 140874 | Class II | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert. | Ameditech Inc |
| Devices | ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine. | Lot No. 141001 | Class II | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert. | Ameditech Inc |
| Devices | Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and revision joint arthoplasty for use in cemented applications. Elbow joint replacement components include humeral and ulnar components, and in some instances, hinge components. | Catalog Number: 414837 Lot Number: 555011 | Class II | An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial. | Biomet, Inc. |
| Devices | AC Powered adjustable bed frame. AC powered adjustable bed frame used in nursing facilities. | PCB900 manufactured between 09/13/2010 and 05/22/2012 | Class II | Firm received several complaints that the head deck actuator bracket had separated from the bed frame. | Primus Medical LLC |
| Devices | V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only. | Lot Number 50775911 | Class II | A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, however the pouch label identifies the expiry date of 2016-11. | KCI USA, Inc. |
WEEK ENDING OCTOBER 18
| Product Type | Product Description | Code Info | Classification | Reason for Recall | Recalling Firm |
|---|---|---|---|---|---|
| Devices | ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required. | 2359 , P032387 , P034422 , P034423 , P034732 , P035210 , P035600 , P035705 , P036000 , P037150 , P038617 , P038752 , P038753 , P038894 , P039590 , P040635 , P040812 , P041044 , P041473 , P041617 , P042386 , P042430 , P042473 , P042474 , P042595 , P042596 , P042657 , P042727 , P042728 , P042842 , P043140 , P043232 , P043521 , P045035 , P045367 , P046255 , P046256 , P047337 , P047480 , P049467 , P049468 , P050432 , P050489 , P052233 , P056073 , P056861 , P056862 , P058743 , P060073 , P060179 , P060529 , P060857 , P060858 , P060918 , P060919 , P060920 , P062505 , P062609 , P062847 , P063301 , P063853 , P064395 , P064483 , P064500 , P064575 , P064719 , P064815 , P064816 , P065140 , P065141 , P065193 , P065314 , P065400 , P065401 , P066218 , P066570 , P066615 , P067019 , P067086 , P067087 , P067393 , P067441 , P067482 , P068002 , P068266 , P068700 , P068988 , P070081 , P070435 , P070443 , P070713 , P070770 , P071349 , P071350 , P071451 , P073778 , P073847 , P073934 , P075170 , P076716 , P076719 , P076849 , P076950 , P078419 , P079322 , P079323 , P080384 , P083938 , P084481 , P084594 , P085062 , P086507 , P086508 , P086830 , P086831 , P087584 , P087585 , P087853 , P088197 , P088210 , P088272 , P088570 , P088655 , P092355 , P093705 , P093834 , P094960 , P094961 , P096673 , P096674 , P096675 , P097132 , P097311 , P097500 , P099166 , P099167 , P099444 , P099445 , P099721 , P100052 , P100053 , PO106703 , PO106704 , PO106706 , PO29057 , PO29058 , PO29059 , PO84691 , PO84692 , PO84693 , PO84694 , PO84695 , PO84696 , PO84697 , PO84698 ; 1) Model Number C1080; Serial Numbers (US): 416930 , 766425 , 473239 , 773201 , 851902 , 416917 , 491904 , 545574 , 473246 , 416932 , 473245 , 473238 , 82730 , 783942 , 416919 , 473243 , 545569 , 473234 , 416920 , 416926 , 473236 , 830902 , 416927 , 491906 , 416931 , 416921 , 491895 , 745779 , 561704 , 561689 , 766423 , 416922 , 774737 , 416925 , 416928 , 491908 , 473242 , 491900 , 822726 , 836910 , 545567 , 473233 , 561700 , 491903 , 836902 , 82996 , 473240 , 745778 , 747442 , 561691 , 561695 , 561701 , 491893 , 545579 , 725635 , 304528 , 304527 , 747444 , 745780 , 473241 , 545573 , 816751 , 816748 , 812748 , 836904 , 304530 , 491896 , 545580 , 545570 , 545568 , 561693 , 774730 , 473232 , 491901 , 725633 , 561699; Serial Numbers (Foreign): 18045 , 18151 , 18152 , 18153 , 18154 , 18155 , 18366 , 93080 , 114143 , 276987 , 366998 , 378830 , 378831 , 386998 , 398332 , 398333 , 442500 , 442501 , 442502 , 475308 , 479362 , 479363 , 479364 , 479365 , 479367 , 493548 , 493549 , 493550 , 493551 , 493552 , 493553 , 493554 , 493555 , 493556 , 493557 , 511571 , 511572 , 511573 , 566464 , 566465 , 602665 , 684642 , 695358 , 701859 , 701948 , 725623 , 725624 , 725625 , 725626 , 725627 , 725629 , 725631 , 745783 , 751632 , 765776 , 765777 , 778573 , 778575 , 778576 , 778577 , 778578 , 822721 , 822721 , 822730 , 822730 , 822731 , 822732 , 830904 , 830905 , 831024 , 831025 , 840921 , 844771 , 848196 , 848199 , 848203 , 848206 , 848207 , 848931 , 857830 , 857831 , 871844 , 873308 , 873309 , 873310 , 873311 , 895437 , 895438 , 901247 , 901248 , 904455 , 905470 , 925888 , 925889 , 925890 , 925901 , 929765 , 929766 , 929769 , 934938 , 934939 , 935002 , 945140 , 945142 , 945143 , 945145 , 945146 , 945147 , C1080 , CO10800103 , CO10800104 , CO10800105 , CO10800106 , CO10800107 , D778574 , G/493557 , P0032040 , P0032041 , P0100336 , P0100409 , P0101003 , P0101329 , P0101330 , P0101331 , P0101332 , P0101333 , P0101510 , P0101511 , P0101512 , P0101513 , P0101514 , P0101515 , P01 | Class II | There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40. | Arjo Hospital Equipment AB |
| Devices | ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required. | 1) Model Number: C1000; Serial Numbers (Foreign): 62265 , 399945 , 399946 , 399949 , 416912 , 416914 , 423215 , 475309 , 530882 , 554079 , 554082 , 566463 , 584837 , 586554 , 592203 , 592204 , 592205 , 592206 , 597027 , 597028 , 605859 , 646152 , 664632 , 680670 , 680699 , 693924 , 695671 , 699563 , 712231 , 714227 , 714228 , 714229 , 716809 , 720277 , 725622 , 731631 , 745781 , 745782 , 747354 , 747355 , 748161 , 748162 , 748635 , 761635 , 766430 , 766430 , 766431 , 766431 , 771194 , 771195 , 771197 , 771198 , 798571 , 816742 , 821563 , 821564 , 821704 , 821705 , 821706 , 821707 , 822714 , 823713 , 823713 , 823714 , 832524 , 832525 , 832526 , 832527 , 832528 , 840918 , 840919 , 840919 , 840920 , 840920 , 840922 , 840923 , 840924 , 840925 , 840947 , 840948 , 840949 , 840950 , 847439 , 853387 , 855259 , 855260 , 855261 , 855262 , 871837 , 871840 , 871841 , 871842 , 871843 , 872720 , 873306 , 873307 , 873307 , 881203 , 881204 , 881205 , 881206 , 881207 , 889938 , 889939 , 901232 , 901233 , 901234 , 901236 , 901237 , 901244 , 904448 , 904449 , 904449. , 913969 , 916105 , 916108 , 924589 , 925887 , 929764 , 929772 , 945149 , 945151 , 945154 , 945160 , 8401918 , 648568Z1894 , 648569Z1894 , C1000 , M/M-1 , M/M-10 , M/M-2 , M/M-3 , M/M-4 , M/M-5 , M/M-6 , M/M-7 , M/M-8 , M/M-9 , P0100097 , P0100172 , P0100337 , P0100523 , P0100655 , P0100723 , P0101916 , P0101927 , P0101928 , P0101929 , P0101930 , P0101931 , P0102404 , P0102894 , P0102895 , P0102896 , P0102897 , P0102898 , P0103581 , P0103582 , P0103583 , P0106046 , P0106705 , P0106707 , P0108275 , P0108276 , P0109784 , P0110620 , P0111754 , P0114163 , P0114164 , P0115132 , P0118357 , P0118358 , P0120283 , P0120855 , P0120862 , P0121025 , P0121307 , P0121308 , P0121605 , P0121857 , P0122187 , P0122459 , P0125170 , P0126006 , P0126089 , P0126317 , P0126318 , P0126326 , P0126865 , P0126866 , P0126867 , P0128593 , P0128594 , P0130033 , P0132561 , P0133271 , P0133392 , P0133482 , P013391 , P0134514 , P0137082 , P0137164 , P0137540 , P0138061 , P0138062 , P0138242 , P0138520 , P0138710 , P0138780 , P0138781 , P0139072 , P0143580 , P0143581 , P0143714 , P0144844 , P0144845 , P0145951 , P0146630 , P0146631 , P0146632 , P0147602 , P0147657 , P0147790 , P0147791 , P0147792 , P0148713 , P015878 , P015879 , P015880 , P015881 , P015882 , P015883 , P015884 , P015885 , P015886 , P015887 , P015888 , P015889 , P015890 , P015891 , P015892 , P015893 , P015894 , P015895 , P015896 , P015897 , P016101 , P016102 , P0162202 , P0162203 , P0162204 , P0162368 , P0162369 , P0163463 , P016386 , P016387 , P016388 , P016389 , P016392 , P016394 , P0164651 , P0164652 , P0164972 , P0167357 , P0167465 , P0167466 , P0168015 , P0170588 , P0170689 , P0170690 , P0170968 , P0170969 , P0170981 , P0170982 , P0171406 , P0171918 , P0175182 , P0175368 , P0175369 , P0175370 , P0175545 , P0175546 , P0176591 , P0177062 , P0177063 , P017742 , P0178144 , P0178145 , P0178146 , P0178147 , P0178884 , P0178994 , P0179154 , P0180855 , P0180856 , P0180857 , P0180858 , P0181259 , P0181260 , P0182476 , P0183725 , P0183726 , P0183727 , P0183728 , P0183729 , P0183730 , P0183731 , P0183732 , P0184221 , P0184222 , P0185060 , P0185078 , P0185233 , P0185307 , P0185896 , P0189314 , P0189315 , P0189316 , P019458 , P019459 , P019460 , P019461 , P021789 , P021791 , P021888 , P021894 , P022021 , P022022 , P022023 , P022759 , P022760 , P022761 , P023170 , P025354 , P025355 , P025968 , P025969 , P026033 , P026034 , P026125 , P026126 , P026302 , P026303 , P027324 , P027461 , P027954 , P027956 , P029384 , P031686 , P031774 , P03 | Class II | There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40. | Arjo Hospital Equipment AB |
| Devices | ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required. | 01516 , P0106045 , P0106415 , P0106416 , P0106417 , P0107780 , P0108277 , P0108715 , P0108716 , P0108717 , P0109782 , P0109783 , P0109954 , P0110233 , P0111026 , P0111276 , P0111872 , P0111873 , P0112155 , P0112156 , P0112157 , P0112158 , P0112955 , P0113151 , P0113364 , P0115133 , P0115301 , P0115302 , P0116051 , P0116614 , P0116615 , P0117468 , P0117880 , P0117881 , P0122188 , P0122460 , P0125766 , P0125767 , P0127623 , P0127849 , P0128225 , P0128420 , P0128875 , P0129052 , P0129155 , P0129451 , P0129572 , P0130354 , P0132046 , P0132726 , P0133301 , P0133777 , P0133835 , P0133836 , P0133837 , P0134515 , P0135473 , P0138875 , P0149304 , P0149305 , P0160131 , P0163554 , P0164049 , P0164216 , P0164438 , P0164532 , P0165078 , P0165079 , P0165080 , P0165081 , P0166465 , P0166466 , P0166834 , P0167425 , P0167651 , P0167682 , P0169577 , P0170398 , P0170970 , P0172128 , P0172129 , P0172423 , P0172424 , P0172425 , P0172426 , P0172623 , P0172718 , P0175806 , P0175807 , P0177061 , P0178143 , P0181261 , P0183905 , P0186868 , P0186870 , P0188652 , P018869 , P0189663 , P0189664 , P019147 , P019148 , P019149 , P019150 , P019151 , P019275 , P019276 , P019277 , P019283 , P019322 , P019323 , P019326 , P019327 , P019801 , P019802 , P019803 , P019804 , P020452 , P020453 , P021332 , P021333 , P021792 , P021794 , P022018 , P022019 , P023898 , P023901 , P024623 , P025150 , P025151 , P026436 , P026437 , P026438 , P026439 , P026440 , P026619 , P026620 , P026621 , P026804 , P027081 , P027082 , P027321 , P027322 , P027323 , P027744 , P027953 , P028299 , P030415 , P030416 , P030863 , P030864 , P031143 , P031144 , P031530 , P034344 , P034345 , P034346 , P034424 , P034425 , P034542 , P034611 , P035841 , P035976 , P035977 , P036591 , P039475 , P039476 , P039591 , P039749 , P041222 , P041223 , P041615 , P041616 , P041932 , P041972 , P041973 , P041974 , P042167 , P042282 , P042284 , P042285 , P048169 , P048170 , P050022 , P050433 , P051327 , P051626 , P053704 , P054140 , P054376 , P054593 , P056636 , P056860 , P058001 , P058621 , P058622 , P059546 , P059634 , P059635 , P060675 , P060676 , P062509 , P062978 , P064317 , P065625 , P065806 , P066048 , P067245 , P067504 , P068235 , P068236 , P069079 , P069178 , P069334 , P069335 , P069615 , P070949 , P071725 , P073528 , P075036 , P075802 , P075946 , P076331 , P076526 , P079075 , P079321 , P081497 , P081583 , P081584 , P081854 , P082674 , P083243 , P083666 , P084374 , P086826 , P087950 , P088488 , P094207 , P094411 , P096286 , P097604 , P0M6050 , PO137838 , PO146396 , PO190805 , PO19275 , PO47568 , R61213 | Class II | There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40. | Arjo Hospital Equipment AB |
| Devices | The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton. | Product Code: 4986.09; Lot: 51000232 | Class II | Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The devices are being recalled as a part of an investigation into a biocompatibility test discrepancy where the recalled lot (lot 51000232) passed final release testing, but the subsequent lot failed biocompatibility testing on a component that was also used to manufacture lot 51000232. | Richard Wolf Medical Instruments Corp. |
| Devices | Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open during the surgical procedure. | Barcode: 10603295240532 CATALOG NO. : 962004000 Lot # OSA-149328 Lot # OSA-181610 Lot # OSA-161157 | Class II | The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin. | DePuy Orthopaedics, Inc. |
| Devices | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. | Batch/Lot No. 4767162 (exp. date 30-JUN-15) | Class II | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. | Navilyst Medical, Inc |
| Devices | BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. | Batch/Lot Nos. 4745699 (exp. 31-Jan-16) and 4760237 (31-Jan-16) | Class II | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. | Navilyst Medical, Inc |
| Devices | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. | Batch/Lot No. 4752351 (exp. 31-Jan-16) | Class II | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. | Navilyst Medical, Inc |
| Devices | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No. H965750121, REF/Catalog No. 75-012, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. | Batch/Lot No. 4748676 (exp. 31-Jan-16) | Class II | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. | Navilyst Medical, Inc |
| Devices | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M2309831, REF/Catalog No. 60M230983, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. | Batch/Lot No. 4756773 (exp. 31-May-15) | Class II | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. | Navilyst Medical, Inc |
| Devices | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801 | Batch/Lot No. 4763165 (exp. 31-May-15) | Class II | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. | Navilyst Medical, Inc |
| Devices | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1406071, REF/Catalog No. 60M140607, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801 | Batch/Lot No. 4748898 (exp. 31-May-15) | Class II | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. | Navilyst Medical, Inc |
| Devices | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M1318471, REF/Catalog No. 60M131847, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. | Batch/Lot No. 4754060 (exp. 31-May-15) | Class II | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. | Navilyst Medical, Inc |
| Devices | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0501981, REF/Catalog No. 60M050198, STERILE --- Intended for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. | Batch/Lot No. 4754052 (exp. 30-Apr-15) | Class II | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. | Navilyst Medical, Inc |
| Devices | PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LUMEN, UPN Product No. H96560M0367061, REF/Catalog No. 60M036706, STERILE --- Indicated short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. | Batch/Lot No. 4753216 (exp.30-Apr-15) | Class II | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. | Navilyst Medical, Inc |
| Devices | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. | Batch/Lot No. 4753215 (exp. 30-Apr-15) | Class II | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. | Navilyst Medical, Inc |
| Devices | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0224751, REF/Catalog No. 60M022475, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. | Batch/Lot No. 4753765 (exp. 31-May-15) | Class II | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. | Navilyst Medical, Inc |
| Devices | Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010. | Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. | Class II | Nemschoff Chairs, Inc. is recalling various model of the Serenity Treatment Chair because of potential elevated temperatures in the seat and back lumbar areas of the chair. | Nemschoff Chairs, Inc. |
| Devices | RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal. | J0111, J0211, J0411, J0611, J0911, J1211, NB12649, NB12650, NB12651, NB12652, NB12653, NB12654, NB12655, NB12656, NB23480, NB23481, NB3584, NB3586, NB3587, NB3588, NB3590, NB3591, NB5955, NB7894, NB8016, NB8017, NB8018, NB8019, NB8020, NB8021, NB8022, NB8023, 578910, 578913, R578910, R578912, R578913, 582631, and 592125. | Class II | Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient. | DePuy Orthopaedics, Inc. |
| Devices | RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). | Item 66800058 Lot # M400021 & Item 66800913 Lot # M400067 | Class II | RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. | Smith & Nephew, Inc. |
| Devices | RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). | Item 66800423 Lot # M400058 & Item 66801066 Lot # M400124 | Class II | RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. | Smith & Nephew, Inc. |
| Devices | RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). | Item 66800912 Lot # M400071 | Class II | RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. | Smith & Nephew, Inc. |
| Devices | Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista® System. | lot 3JD045, exp. 2014-10-01; lot 4BD064, exp. 2015-02-01; lot 4CD012, exp. 2015-03-01; and lot 4DD065, exp. 2015-05-01. | Class II | Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability monitoring that exceeds our acceptance criteria for drift over the shelf life of this product. Siemens has observed drift from 3% to 12% at MMB concentrations across the assay range. Depending on quality control limits, this drift may not have been detected. Due to the drift, Siemens is revising the expiration date of this product. | Siemens Healthcare Diagnostics, Inc. |
| Devices | Philips Healthcare Integris Allura 15 -12 | Model Number: Integris Allura 15-12 Serial Number: 16741023 | Class II | Philips had discovered through a field service testing where a device failed to comply with a Federal standard. | Philips Medical Systems, Inc. |
| Devices | GE Healthcare Carescape Patient Data Module | Mfg Lot or Serial #
SA307020379GR SA307020383GR SA307020386GR SA307020391GR SA307020393GA
SA307020396GA SA307020397GA SA307020399GR SA307020400GA SA307030405GR
SA307030411GR SA307030412GR SA307030413GR SA307030417GA SA307030419GA
SA307030420GA SA307030423GA SA307050429GA SA307070436GR SA307070438GR
SA307070441GR SA307070442GR SA307070446GA SA307070447GR SA307070448GA
SA307070449GR SA307070450GR SA307070453GR SA307070454GR SA307070455GR
SA307080459GA SA307080462GR SA307080463GR SA307080466GA SA307080467GA
SA307080469GA SA307080472GA SA307080473GR SA307080477GR SA307080478GR
SA307080484GA SA307080488GA SA307080489GA SA307080491GA SA307080493GR
... More |
Class II | GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform and its associated waveform parameters could be analyzed incorrectly. | GE Healthcare, LLC |
| Devices | Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek® and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE | Model/Product Number: B30-102 Lot #416130 Exp. 12/2016 | Class II | Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insufficient application of glue. Recall was initiated due to the rate of the failure. | Biomedix, Inc. |
| Devices | Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. | Product Code: 426-796 Lot Number: 298987 | Class I | The affected lots could have NBF concentrations that are lower or higher than the desired specifications. | Richard-Allan Scientific Company |
| Devices | Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. | Product Code: 534801 Lot Number: 296986 | Class I | The affected lots could have NBF concentrations that are lower or higher than the desired specifications. | Richard-Allan Scientific Company |
| Devices | Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. | Product Code: LC-0060 Lot Number: 300445 | Class I | The affected lots could have NBF concentrations that are lower or higher than the desired specifications. | Richard-Allan Scientific Company |
| Devices | Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. | Product Code: 59601 Lot Number: 300233 | Class I | The affected lots could have NBF concentrations that are lower or higher than the desired specifications. | Richard-Allan Scientific Company |
| Devices | Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. | Product Code: 51401 Lot Number: 300649 | Class I | The affected lots could have NBF concentrations that are lower or higher than the desired specifications. | Richard-Allan Scientific Company |
| Devices | Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. | Product Code: 53151 Lot Number: 300143 | Class I | The affected lots could have NBF concentrations that are lower or higher than the desired specifications. | Richard-Allan Scientific Company |
| Devices | Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. | Product Code: C4320-450B Lot Number: 300403 | Class I | The affected lots could have NBF concentrations that are lower or higher than the desired specifications. | Richard-Allan Scientific Company |
| Devices | Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma. | Catalog numbers: 32-481000 Lot Numbers: 615860, 765230 Catalog Number: 32-481001 Lot Number Identification: 121450, 392410, 765250, 974290 | Class II | Investigation determined that units supplied were missing the 4x21 degree helix angle. | Biomet, Inc. |
| Devices | Biosense Webster's Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577. | Lot Numbers: 1717945, 1721574, 1721575 and 1723123 Catalog Nos: M-5723-115, Model Number BIO10438577 | Class II | Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is connected with the CARTO®3 System, Error 6103 for expiration is displayed on the CARTO®3 System and the catheter cannot be used. | STERILMED, INC. |
| Devices | Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only. | Catalog Number: 110010849 Lot Number: 169620, 253190 | Class II | An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use. | Biomet, Inc. |
| Devices | Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only. | Catalog Number: 110010850 Lot Number: 231120, 253210 | Class II | An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use. | Biomet, Inc. |
| Devices | Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only. | Catalog Number: 110010851 Lot Number: 139800, 139810, 139820 | Class II | An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use. | Biomet, Inc. |
| Devices | McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. | McKesson CardiologyTM Hemo versions: 13.0, 13.0HF1, 13.0HF2, 13.0HF3, 13.1. | Class II | Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations. | Mckesson Information Solutions LLC |
| Devices | StarMedTec LightTrail® Reusable Fibers, 365 um; Material/Part Number: 6453 | Material/Part Number: 6453 Batch Code: 2011-00238 | Class II | Product is not cleared for use with lasers other than the Auriga XL system | Boston Scientific Corporation |
| Devices | StarMedTec LightTrail® Reusable Fibers, 600 um; Material/Part Number: 6455 | Material/Part Number: 6455 Batch Code: 2012-00268, 2013-00443 | Class II | Product is not cleared for use with lasers other than the Auriga XL system | Boston Scientific Corporation |
| Devices | StarMedTec LightTrail® Reusable Fibers, 800 um; Material/Part Number: 6457 | Material/Part Number: 6457 Batch Code: 2011-00217, 2012-00239, 2012-00249, 2012-00258 | Class II | Product is not cleared for use with lasers other than the Auriga XL system | Boston Scientific Corporation |
| Devices | ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. | Lot Numbers: 1614, 1814, 1914 | Class II | Product sterility is not assured | Bio-Detek, Inc. |
| Devices | ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. | Lot Numbers: 1614, 1814 | Class II | Product sterility is not assured | Bio-Detek, Inc. |
| Devices | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. | Lot Numbers: 1614, 1914, 2114 | Class II | Product sterility is not assured | Bio-Detek, Inc. |
| Devices | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. | Lot Numbers: 1614, 1914, 2114 | Class II | Product sterility is not assured | Bio-Detek, Inc |
WEEK ENDING OCTOBER 11
Covidien announced that it has notified customers of a Field
Safety Alert for certain Medi-Trace™ Cadence and Kendall™ Multi-function
Defibrillation Electrodes due to a connector compatibility issue with Philips
FR3 and FRx Defibrillators.
These electrodes will not connect with Philips FR3 or FRx AED units, and in the
case of the use of Covidien defibrillation electrodes with the Philips FR3 AED
units, could result in a delay of therapy. The FRx AED unit requires the pads to
be pre-connected, and will issue a continuous alarm chirp to alert the user that
the proper pads are not connected to the unit prior to use. The FR3, however,
does not require pre-connection and the user will not discover the compatibility
issue until the AED must be used. This may result in a delay in therapy.
Philips FR3 and FRx AED units should only be used with the Philips brand
electrodes specified in the equipment manual.
The Field Safety Alert requests that customers review the use of
Covidien defibrillation electrodes in their facility to assure that Covidien
electrodes are not placed for use with Philips model FR3 or FRx AEDs.
There are a total of 644,460 electrodes affected by this safety alert.
The following Covidien electrodes are affected:
In addition, similar private label electrodes produced by Covidien were also
distributed under the following brands, and have the same connector
compatibility issue:
The Field Safety Alert applies to all lot numbers distributed
globally.
For further information or to report a problem, please contact Covidien Quality
Assurance at 1-800-962-9888, option 8, then extension 2500 between the hours of
8 a.m. and 5 p.m. (eastern) or email [email protected]
| Product Type | Product Description | Code Info | Classification | Reason for Recall | Recalling Firm |
|---|---|---|---|---|---|
| Devices | Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers. | Part Number: 20-009-018; Lot Numbers: 051713018B, 052413018C | Class II | There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP. | Nanosphere, Inc. |
| Devices | Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers. | Part Number: 20-009-021; Lot Numbers: 052113021C | Class II | There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP. | Nanosphere, Inc. |
| Devices | CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50 | Part number CT-H25 with
the following lot numbers: 3244680000, 3446210000, 3246280000,
3246480000, 3246490000, 3246970000, 3247020000, 3247030000,
3247130000, 3247440000, 3247670000, 3247680000, 3247980000,
3248070000, 3248200000, 3248300000, 3249120000, 3249130000,
3249140000, 3249150000, 3249160000. Part number CT-H50 with the
following lot numbers: 324782, 324796, 324797, 3245120000, 3245670000,
3245680000, 3246270000, 3246490000, 3246690000, 3246700000,
3246940000, 3246980000, 3247140000, 3247160000, ... More |
Class II | Blade can shift during shipping which makes the product ineffective. | KCI USA, Inc. |
| Devices | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. | 1) Instrumed Item No.:
250-08800; Adler Instrument Company Catalog Code: 70-0300; Lot Number:
070113; 2) Instrumed Item No.: 250-08860 ; Adler Instrument Company
Catalog Code: 70-0319; Lot Number: 030312, 070411; 3) Instrumed Item
No.: 250-08930; Adler Instrument Company Catalog Code: 70-0318; Lot
Number: 010113, 020113, 030112, 050412, 060413, 070512, 090213, ... More |
Class II | Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." | Instrumed International, Inc. |
| Devices | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. | 1) Instrumed Item No.: 250-08930; Ambler Surgical Corporation Catalog Code: J647-6; Lot Number: 060412; | Class II | Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." | Instrumed International, Inc. |
| Devices | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. | 1) Instrumed Item No.:
250-08680; Boss Instruments Catalog Code: 35-8015; Lot Number: 030411,
100110, 110210; 2) Instrumed Item No.: 250-08700; Boss Instruments
Catalog Code: 35-8016; Lot Number: 030111; 3) Instrumed Item No.:
250-08700; Boss Instruments Catalog Code: 35-8016; Lot Number: 30111;
4) Instrumed Item No.: 250-08760; Boss Instruments Catalog Code:
... More |
Class II | Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." | Instrumed International, Inc. |
| Devices | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. | 1) Instrumed Item No.:
250-08570; CareFusion Catalog Code: VM46-9112-1; Lot Number: 010111;
2) Instrumed Item No.: 250-08600; CareFusion Catalog Code: LA8523 ;
Lot Number: 070211, 070213, 090412; 3) Instrumed Item No.: 250-08610;
CareFusion Catalog Code: LA8523-45; Lot Number: 042011, 062209; 4)
Instrumed Item No.: 250-08620; CareFusion Catalog Code: LA8515; Lot
Number: ... More |
Class II | Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." | Instrumed International, Inc. |
| Devices | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. | 1) Instrumed Item No.: 250-08930; Pilling Weck Inc. / Teleflex Medical Catalog Code: 728163; Lot Number: 66745 | Class II | Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." | Instrumed International, Inc. |
| Devices | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. | 1) Instrumed Item No.: 250-08930; Specialty Care Catalog Code: 30-92221; Lot Number: 040413 | Class II | Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." | Instrumed International, Inc. |
| Devices | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. | 1) Instrumed Item No.:
250-08860; Symmetry Surgical Inc. ... More |
Class II | Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." | Instrumed International, Inc. |
| Devices | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. | 1) Instrumed Item No.: 250-09010; Phoenix Instruments Catalog Code: 190-9523; Lot Number: 070411; 2) Instrumed Item No.: 250-09040; Phoenix Instruments Catalog Code: 190-9527; Lot Numbers: 010211, 040411 | Class II | Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." | Instrumed International, Inc. |
| Devices | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. | 1) Instrumed Item No.:
250-08930; Surgical Direct Catalog ... More |
Class II | Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." | Instrumed International, Inc. |
| Devices | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. | 1) Instrumed Item No.: 250-08660; Surgimed - MLB Catalog Code: 91-112; Lot Numbers: 040110, 100112 | Class II | Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." | Instrumed International, Inc. |
| Devices | The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, WB and SPECT applications. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction. The Symbia T2 integrates state-of-the-art SPECT and high quality dual slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia T6 integrates state-of-the-art SPECT and high quality six slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia T16 integrates state-of-the-art SPECT and high quality sixteen slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. For the Symbia T16/T6/T2, the ultra fast multi-slice spiral CT maximizes confidence in diagnostic stand-alone CT, as well as precise attenuation correction and anatomical mapping. Acquisitions can be performed with either the CT preceding the nuclear acquisition or vice versa. Indications for use: SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. | 1) Symbia T; Product Code:
10275007; Serial Numbers: 1055 , 1056 , 1057 , 1058 , 1060 , 1061 ,
1062 , 1063 , 1064 , 1065 , 1066 , 1067 , 1068 , 1069 , 1070 , 1071 ,
1072 , 1073 , 1074 , 1075 , 1076 , ... More |
Class II | Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. The event does not pose a hazard by itself but could lead to a rupture of the drive belt which in turn could damage the gantry covers and make contact with the patient. | Siemens Medical Solutions USA, Inc. |
| Devices | The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, whole body (WB) and SPECT applications. The Symbia Intevo Excel integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction. The Symbia Intevo 2 integrates state-of-the-art SPECT and high quality dual slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia Intevo 6 integrates state-of-the-art SPECT and high quality six slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia Intevo 16 integrates state-of-the-art SPECT and high quality sixteen slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. Indications for use: SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. | 1) Symbia Intevo Excel; Product Code: 10764801; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1009 , 1010 , 1011 , 1012 , 1013 , 1014 ; 2) Symbia Intevo 2; Product Code: 10764802; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 ; 3) Symbia Intevo 6; Product Code: 10764803; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 ; 4) Symbia Intevo 16; Product Code: 10764804; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 , 1012 , 1013 , 1014 , 1015 | Class II | Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. The event does not pose a hazard by itself but could lead to a rupture of the drive belt which in turn could damage the gantry covers and make contact with the patient. | Siemens Medical Solutions USA, Inc. |
| Devices | ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. | Lot 4014, Expiration date 07/2015; Lot 4051, Expiration date 09/2015; Lot 4074, Expiration date 11/2015; | Class III | Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached. | ELITech Clinical Systems SAS |
| Devices | Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation. | Material 100077113, Batch 4558337 | Class II | The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals. | St. Jude Medical, Inc. |
| Devices | Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation. | Material 100077108, Batch 4519182 | Class II | The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals. | St. Jude Medical, Inc. |
| Devices | Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2, Sterilized using irradiation, single use. | Lot Numbers: 62155015 62165014 62165015 62165016 62165017 62165018 62182742 62182743 62188282 62188283 62191355 62191361 62191366 62191372 62210290 62210291 62227943 62230668 62230669 62230670 62230671 62230672 62230673 62230674 62230675 62230676 62255591 62255592 62255593 62255594 62255595 62255596 62255597 62255598 62283576 62283577 62283578 62288220 62288221 62288222 62288223 62288224 62305911 62305912 62305913 62305914 62327983 62327985 62327987 62327988 62327989 62348078 62348079 62348080 62348091 62348092 62348095 62379888 62379889 62379890 62379891 62391801 62391802 62391803 62391804 62391805 62391807 62391808 62408432 62408438 62408439 62408440 62408441 62417035 62417036 62417037 62444920 62444921 62444922 62444925 62453583 62453584 62453585 62475432 62475433 62475434 62475435 | Class II | The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver. | Zimmer, Inc. |
| Devices | The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated for relief from general aches and pains brought on by changes in the weather. | All Lots, Series and Codes | Class II | The firm is distributing the Rejuvenator device without an approved 510(k). | Baro-Therapies, Inc |
| Devices | Siemens Dimension Vista® CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista® System. | lot 3GM081, exp. 07-01-2014 | Class II | Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® CHEM 1 CAL, lot 3GM081. Investigation by Siemens confirms that QC and patient samples under-recovers MG by 0.25 mg/dL [0.10 mmol/L] across the assay range following calibration with 3GM081. | Siemens Healthcare Diagnostics, Inc. |
| Devices | eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray | Models: eXpert DC, NA, 75
Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch
reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach;
eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy,
Articulated Arm & Tubehead, eDC; and Assy, Articulated ... More |
Class II | Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being installed onto the assembled articulated arm. | Gendex Corp |
| Devices | ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. | All serial numbers. Model Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008, 10327379, 10328250, 10328647, 10329364, 10330873, 10331013, 10332617, 10334139, 10334759, 10337512, 10337526, 10339677, 10340551, 10340737, 10341051, 10341110, 10361010, 10361011, 10361012 | Class II | The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the LIS is merged with the next order. This issue can occur when the LIS data buffer on the ADVIA Centaur system becomes full and a particular character is found in the last five locations in the LIS data buffer. In this case, the incorrect patient demographic information will be transmitted to the LIS and will be displayed on the ADVIA Centaur user interface and instrument generated printed reports. | Siemens Healthcare Diagnostics |
| Devices | ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. | All serial numbers. Model Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696, 10471899 | Class II | The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the LIS is merged with the next order. This issue can occur when the LIS data buffer on the ADVIA Centaur system becomes full and a particular character is found in the last five locations in the LIS data buffer. In this case, the incorrect patient demographic information will be transmitted to the LIS and will be displayed on the ADVIA Centaur user interface and instrument generated printed reports. | Siemens Healthcare Diagnostics |
| Devices | VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. | Lot Number 2613-0150-4913, exp. 15-Nov-2014 | Class II | Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some positively biased results were identified during testing of a different VITROS PHYT Slide lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the same event, there is the potential for slides from this lot to also be affected. | Ortho-Clinical Diagnostics |
| Devices | SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids. | Software Versions
5.02.06, 6.02.06, and 6.02.11; Affected Serial Numbers: 712090,
723687, 723842, 724966, 725820, 735977, 751130, 752124, 755174,
768538, 771990, 774743, 781406, 783736, 784698, 794466, 805797,
808901, 809113, 812462, 815932, 842120, 857926, 858672, 862085,
863721, 865630, 873459, 889597, 890260, 903748, 912619, 920574,
920589, 956346, 957394, 965402, 966684, 976931, 977550, 978361, ... More |
Class II | One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014. | Baxter Healthcare Corp. |
| Devices | LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions. | Lap-Band System AP Standard Catalog Number B-2240; Serial Numbers: 17760203, 17704664, 17704665, 17760205, 17760179, 17704672, 17704667, 17704659, 17760194, 17704653 | Class II | Product was distributed past its expiration date. | Apollo Endosurgery Inc |
| Devices | Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and Structural Abnormalities of the Retina and Choroid including: " Proliferative and Severe and Very Severe Non-Proliferative Diabetic Retinopathy " Macular Edema associated with Proliferative or Non-Proliferative Diabetic Retinopathy " Choroidal Neovascularization " Retinal Neovascularization associated with Retinal Occlusive Disease (Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion) " Macular Edema associated with Branch Retinal Vein Occlusion " Retinal Tears and Detachments And Anterior Segments as follows: " Iridotomy in Closed Angle Glaucoma " Trabeculoplasty in Open Angle Glaucoma | All assembled units since product release, Part Number: GA-0006700. | Class II | Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern. | Lumenis, Inc. |
| Devices | Philips Expression MR200 MRI Patient Monitoring System Model 866120 | Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013 | Class II | During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient. | Invivo Corporation |
| Devices | Hudson RCI® Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product Usage: To administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Ypiece. | Product Code: 313905, Lot
#02F1300085; Product Code: 353900, ... More |
Class I | The pediatric breathing circuits can crack prior to and during use. | Teleflex Medical |
| Devices | ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. | PATIENT SIDE CART, PS4000. Part Number: 380652 Serial Numbers: 353668 351929 354943 351749 354389 351849 355824 363594 361993 360419 358104 357083 351852 351845 361323 358107 364412 364505 361994 364001 349166 364112 358774 359361 357082 363784 353632 364343 358109 358848 351052 354234 354552 356258 363752 354233 358775 364200 359222 364619 363868 354714 361989 361391 361094 351853 353410 355206 357698 358480 365395 359223 355996 363681 360417 355623 365465 365839 356530 364620 365928 365862 356532 366904 366884 367674 368046 367426 356683 360413 356533 368071 368681 358930 357081. | Class II | Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a mid-procedure restart. | Intuitive Surgical, Inc. |
| Devices | The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional 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 | Ingenuity CT: 728326 300005,300010,300012,300016,300017,300019,300020,300021,300028,300029, 300031,300032,300033,300035,300037,300039,300043,300047,300050,300051, 300052,300054,300055,300057,300060,300061,300062,300063,300072,300074, 300082,300086,300087,300089,300094,300095,300100,300101,300102,300106, 300108,300110,300112,300113,300129,300135,300136,300140,300143 Ingenuity Core: 728321 310001,310002,310009,310055,310059,310064,310069,310070,310087,333015 Ingenuity Core128: 728323 300137,320003,320005,320006,320018,320024,320029,320030,320033,320037, 320078,320092,320099,320103,320114,336011,336012,336013,336016,336018 | Class II | Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user. | Philips Medical Systems (Cleveland) Inc |
| Devices | Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. | Siemens Ysio Max material #s: 10762470, serial numbers: 24033 24028 24024 24034 24015 24026 24014 24016 24025 24037 | Class II | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images have been sent to PACS or hardcopy/filming, thus leading to potentially incorrect diagnosis. | Siemens Medical Solutions USA, Inc |
| Devices | Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. | Siemens AXIOM Luminos dRF Max system material #s: 10762471 with serial number: 5037. | Class II | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images have been sent to PACS or hardcopy/filming, thus leading to potentially incorrect diagnosis. | Siemens Medical Solutions USA, Inc |
| Devices | Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including but not limited to: "Querying and retrieving patient history information and/or previous diagnosis and images from other modalities; "X-ray examinations of the urogenital area "Ultrasound examinations "Endourological interventions "Percutaneous interventions "Laparoscopy "Application of fistula "Simple procedures "Extracorporeal shock wave lithotripsy "Uroflow/urodynamics "Pediatric radiological and therapeutic applications | Siemens Uroskop Omnia Max system, material #s: 10762473, serial numbers: 4014 4015 | Class II | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images have been sent to PACS or hardcopy/filming, thus leading to potentially incorrect diagnosis. | Siemens Medical Solutions USA, Inc |
| Devices | Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations. | Siemens Luminos Agile Max system material #s: 10762472, with serial numbers: 61013 61015 61011 61014 61017 | Class II | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images have been sent to PACS or hardcopy/filming, thus leading to potentially incorrect diagnosis. | Siemens Medical Solutions USA, Inc |
| Devices | GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations. | Mfg Lot or Serial #
System ID 00000015997MO7 260347RF 00000149474MO9 423778ENRF1
00000149476MO4 216343R1 00000149477MO2 423778ERF1 00000149478MO0
407296PRE 00000149479MO8 765482WR2 00000149480MO6 478633PDI3
00000149481MO4 404321P500D 00000149482MO2 435865500D 00000149483MO0
210297NCRF1 00000149484MO8 334705EA3 00000149485MO5 314577GC64
00000149486MO3 423224RF1 00000149487MO1 847432HP8 00000149488MO9
423778ERF2 00000149489MO7 210616MCTRF 00000149490MO5 773633EP500
00000149491MO3 763520N8 00000149492MO1 773CMHCSRF 00000149493MO9
904202RF 00000149495MO4 208557RM1 00000149496MO2 ... More |
Class II | GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging systems. | GE Healthcare, LLC |
WEEK ENDING OCTOBER 4
| Product Type | Product Description | Code Info | Classification | Reason for Recall | Recalling Firm |
|---|---|---|---|---|---|
| Devices | Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System | Mini System part no. IS1100 - lot 0001-0047; Instrument part nos. IS1103, IS1104, and IS1105 - lots 918101, 918102, and 918103 | Class II | Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set. | Instratek, Incorporated |
| Devices | Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion). | The devices being recalled have a catalog number of G826 and a lot number of 11406. | Class II | The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured using Stainless Steel in the center Post instead of the specified titanium alloy. | Genesys Orthopedics Systems, LLC |
| Devices | EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455 | Part number 9079-VC-005; lot code 3606455 | Class II | The voluntary recall is due to the needle set not meeting its specifications. | Vidacare Corporation |
| Devices | eye-pak 7407 Tray Support Cover REF 8065740745 | Item Number 8065740745 with Lot numbers 613207-07V, 613221-07V, 613228-07V, 613249-07V, 613256-07V, 35206V, and 352699V. | Class II | The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured. | Alcon Research, Ltd. |
| Devices | The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure. | Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm) | Class II | UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation. | Argon Medical Devices, Inc |
| Devices | The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures. | Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm) | Class II | UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation. | Argon Medical Devices, Inc |
| Devices | UltraStream Peel Away Kit The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure. | Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm) | Class II | UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation. | Argon Medical Devices, Inc |
| Devices | Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel device aids in the lifting, transfer and lowering to safe position, of a patient. This is accomplished by placing a sling under the patient, and attaching the sling to a spreader bar that is connected to a lifting arm jig via a connection to the spreader bar that allows a swiveling up-down movement. Using battery power, an actuator then powers the lifting arm upwards so that the patient in the sling is lifted from, typically, a bed or chair. | Model Numbers: HMA0002 and HMB002-US; Serial Numbers: MPLAT0409W1177 ; MPLAT0410W1213 ; MPLAT0410W1228 ; MPLAT0410W1229 ; MPLAT0410W1231 ; MPLAT0410W1232 ; MPLAT0412W1290 ; MPLAT0412W1296 ; MPLAT0412W1297 ; MPLAT0502W1403 ; MPLAT0502W1404 ; MPLAT0503W1485 ; MPLAT0503W1486 ; MPLAT0504W1518 ; MPLAT0504W1519 ; MPLAT0504W1520 ; MPLAT0504W1531 | Class II | ArjoHuntleigh received three reports where the bolt under the scale unscrewed from the scale. There is a remote risk concerning the bolt unscrewing from the scale. When the scale and bolt parts are not correctly serviced, or when they receive a sharp blow during or outside of use, it is possible the bolt holding the spreader bar to the scale could unscrew during subsequent use. As a result, the spreader bar can eventually fully unscrew and become detached from the scale and the lift arm, and drop to the floor. Consequently, the person suspended in the sling that is hooked up to the spreader bar could also drop, and/or the spreader bar could drop onto the person, causing serious injury. | ARJOHUNTLEIGH POLSKA Sp. z.o.o. |
| Devices | AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures | material number 3771750, model numbers: 5904441, 5904466, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, and 10280959 | Class II | There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand switch operated at the patient table which may result in uncontrolled release of an x-ray image. | Siemens Medical Solutions USA, Inc |
| Devices | Artis zee and Artis zeego systems. x-ray, angiographic system | running software version VC21B 10094135, 10094137, 10094141, 10280959 with multiple serial numbers . | Class II | There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances, the release of radiation can become blocked unnecessarily. | Siemens Medical Solutions USA, Inc |
| Devices | The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures). | 1) Item reference: 73P20B
, Batch number: 1902 , Expiration date: 09/2018 ... More |
Class II | A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. | Peters Surgical |
| Devices | The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOFLON Evolution sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures). | 1) Item reference: 73P20B
, Batch number: 1902 , Expiration date: 09/2018 ... More |
Class II | A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. | Peters Surgical |
| Devices | CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. | All lots of the following
products: 1) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product ... More |
Class II | The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient. | Carefusion 2200 Inc |
| Devices | VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagent Packs contained within it. Each Reagent Pack can test for 100 samples (patient, Quality Control, etc.). | Lot 9090 (exp. December 15, 2014) | Class II | VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to an approximate signal loss of up to 66.2% which can result in unexpected negative test results being obtained for reactive sample fluids (quality control and patient samples). | ORTHO-CLINICAL DIAGNOSTICS |
| Devices | 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits. | 0.9% Sodium Chloride
Injection, USP BD PosiFlush(TM) Syringes Ref #306553, Lot Numbers
4128353, 3046276, 3024261 were utilized in the following Centurion
convenience kits: Kit ... More |
Class II | Unit packages may exhibit open seals which impacts package integrity and potentially product sterility. | Centurion Medical Products Corporation |
| Devices | CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations. | SERIAL # ENVE CUSTOMER
UNITS: 26562 44554 44559 45317 45322 45324 45328 45330 45333 45334
45336 45339 45341 45343 45736 45737 45740 45741 45742 45744 45745
45750 45751 45752 45907 45908 46040 46041 46043 46044 46050 46051
46632 46636 46641 46642 46643 46644 46645 46646 47069 47071 47073
47075 47076 ... More |
Class I | CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters correctly aligned to function properly. Incorrect alignment may cause the pins in the connector to bend, causing the PTV AC power adapter and/or PTV Auto Lighter Power Cord to be shortened, and preventing charge to the ventilator battery. | CareFusion 203, Inc. |
| Devices | The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram negative bacteria as determined by gram stain. | Product Number: 20-009-021; Lot Number and Expiration Date: Lot: 100113021C, Expiration Date: 03/30/14 | Class II | Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays. | Nanosphere, Inc. |
| Devices | The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile. | Product Number: 20-009-022; Lot Number and Expiration Date: Lot: 100313022B, Expiration Date: 04/01/14 | Class II | Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays. | Nanosphere, Inc. |
| Devices | The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-UP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria. BC-UP detects and identifies the following bacterial genera and species: Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Enterococcus faecalis, Enterococcus faecium, Streptococcus spp., Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus, group and Listeria spp. In addition, BC-UP detects the mnecA resistance marker, inferring mecA-mediated, methicillin resistance, and the vanA and vanB resistance markers, inferring vanA/vanB-mediated vancomycin resistance. In mixed growth, BC-UP does not specifically attribute van-mediated vancomycin resistance to either E. faecalis or E. faecium, or mecA-mediated methicillin resistance to either S. aureus or S. epidermidis. BC-UP is indicated for use in conjunction with other clinical and laboratory findings to, aid in the diagnosis of bacterial bloodstream infections; however, is not to be used to, monitor these infections. Sub-culturing of positive blood cultures is necessary to recover, organisms for susceptibility testing, identification of organisms not detected by BC-UP, differentiation of mixed growth, association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing. | Product Number: 20-009-018; Lot Numbers and Expiration Dates: 1) Lot: 090613018B, Expiration Date: 03/05/14; 2) Lot: 091413018B, Expiration Date: 03/13/14; 3) Lot: 091713018C, Expiration Date: 03/16/14; 4) Lot: 091813018B, Expiration Date: 03/17/14; 5) Lot: 092113018C, Expiration Date: 03/20/14; 6) Lot: 100213018B, Expiration Date: 03/31/14 | Class II | Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays. | Nanosphere, Inc. |
| Devices | The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection, if used in conjunction with other clinical and laboratory findings. Negative results for Influenza A, Influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for Influenza A Virus were established when Influenza A/H3, A/H1, and 2009 H1N1 were the predominant Influenza A viruses circulating. These characteristics may vary when other Influenza A viruses are emerging. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions used specifically for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. | Product Number: 20-009-020; Lot Number and Expiration Date: Lot: 091113020B, Expiration Date: 03/10/14 | Class II | Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays. | Nanosphere, Inc. |
| Devices | The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated Nanosphere Verigene System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the following pathogenic bacteria: - Campylobacter Group (comprised of C. coli, C. jejuni, and C. lari), - Salmonella species, - Shigella species (including S. dysenteriae, S. boydii, S. sonnei, and S. flexneri), - Vibrio Group (comprised of V. cholerae and V. parahaemolyticus), - Yersinia enterocolitica. In addition, EP detects the Shiga toxin 1 gene and Shiga toxin 2 gene virulence markers. Shiga toxin producing E. coli (STEC) typically harbor one or both genes that encode for Shiga Toxins 1 and 2. EP is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological information; however, is not to be used to monitor these infections. EP also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. Due to the limited number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Yersinia enterocolitica, Vibrio Group and Shigella species were primarily established with contrived specimens. Concomitant culture is necessary for organism recovery and further typing of bacterial agents. EP results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative EP results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease. | Product Number: (Not Applicable); Lot Numbers and Expiration Dates: 1) Lot: 091313023CIUO, Expiration Date: 03/12/14; 2) Lot 092713023CIUO, Expiration Date: 03/26/14 | Class II | Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays. | Nanosphere, Inc. |
| Devices | No packaging. Device is a wheel chair. Fuze T50, Fuze T20 and Fuze T50 Jr | Fuze T50, Fuze T20 and Fuze T50 Jr 52752 52794 52750 52667 52679 52692 52729 52745 52779 52826 52865 52878 52823 52912 52804 52666 52680 52702 52731 52746 52780 52827 52866 52879 52749 52913 52753 52669 52682 52703 52732 52747 52781 52828 52867 52880 52696 52796 52734 52670 52681 52695 52735 52768 52782 52856 52868 52881 52748 52705 52701 52671 52683 52707 52736 52770 52802 52857 52869 52882 52825 52699 52698 52672 52684 52708 52737 52771 52803 52858 52870 52883 52829 52706 52834 52668 52685 52710 52738 52772 52805 52859 52871 52884 52916 52751 52821 52673 52687 52709 52739 52773 52806 52860 52872 52885 52767 52799 53192 52674 52690 52711 52740 52774 52807 52861 52873 52886 52795 52914 52663 52676 52688 52726 52741 52775 52808 52862 52874 52887 52919 52824 52664 52677 52691 52728 52742 52776 52809 52863 52876 52888 52831 52918 52665 52675 52693 52727 52743 52777 52810 52864 52877 52889 52754 52917 52733 52678 52694 52730 52744 52778 52811 | Class II | The hex bolt head might shear and cause the axle plate to detach from the lower frame of the wheelchair and could collapse the wheels while in use. | Pdg Product Design Group Inc |
| Devices | BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 3065553. Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Saline Flush Syringes are generally compatible for use with syringe pumps. | REF #306533 Lot numbers 3024261 - exp 12-2015 3046276 - exp 01-2016 4128353 - exp 04-2017 | Class II | BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306533). | Becton Dickinson & Company |
| Devices | STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. | Lot # 2768416 | Class I | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended. | ICU Medical, Inc. |
| Devices | STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. | Lot # 2768417 | Class I | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended. | ICU Medical, Inc. |
| Devices | 83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. | Lot # 2801951 | Class I | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended. | ICU Medical, Inc. |
| Devices | 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. | Lot # 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL | Class I | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended. | ICU Medical, Inc. |
| Devices | No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body. | Model 728243 Software version 2.2.1 and 2.2.2 | Class II | When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate. | Philips Medical Systems (Cleveland) Inc |
| Devices | ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium). | All Lots | Class II | Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has been updated. Horiba has updated the ABX PENTRA Magnesium RTU package inserts by removing the 7-day on-board stability claim and replacing it with a 1-day on-board stability claim. | Horiba Instruments, Inc dba Horiba Medical |
| Devices | UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls. | Sample probe cables, Lot
number 2014. Serial No. 600785 601704 900359 900950 601257 600968
900613 604013 603950 604006 603963 603972 604002 604008 603995 604004
603939 603940 603932 603934 603978 603998 604009 603948 603945 603977
603956 603933 604007 603929 604019 604017 604012 603935 603941 603997
603996 604000 603976 604014 601897 604005 603955 603944 603942 601801
603962 603928 603992 603993 603982 603991 603971 603970 603983 603980
603964 603986 603985 603984 603967 603981 603969 603994 603943 603957
603953 604001 604016 603973 900939 603951 600525 900231 601251 603936
601831 603545 6303547 602589 900913 603859 603860 900368 900935 603078
900782 601493 606694 603693 602113 602595 900933 603917 600571 601220
601265 603013 600794 600306 601718 602771 602782 601925 600758 600857
603007 601658 603717 602020 601894 600891 600882 600980 602036 603539
603706 603975 900940 603999 601510 601381 900947 601624 603946 603949
603947 603952 603016 602996 603974 601509 601513 601928 900834 600931
600693 600511 600341 900264 601969 601109 600113 601791 600959 603931
603966 600680 601305 601872 603503 603125 603915 603988 601255 604003
603965 603989 900851 900826 601984 602278 900765 602356 900581 600343
900948 602313 900057 600912 602360 601828 ... More |
Class II | Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may been installed on newly manufactured and/or recently serviced UniCel DxI 600 and 800 Access Immunoassay Systems, UniCel DxC 660i, 680i, and 860i, and UniCel DxC 880i Synchron Access Clinical Systems instruments. Use of a nonconforming sample probe cable can casuse a delay in reporting results, but will not cause erroneous results. | Beckman Coulter Inc. |
| Devices | Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. | Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN). | Class II | Disposable Patient Circuit that allows water to leak into the center gas lumen | Vapotherm, Inc. |
| Devices | Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. | Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN). | Class II | Disposable Patient Circuit that allows water to leak into the center gas lumen | Vapotherm, Inc. |
| Devices | Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. | Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN). | Class II | Disposable Patient Circuit that allows water to leak into the center gas lumen | Vapotherm, Inc. |
| Devices | Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR ® System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. | Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN). | Class II | Disposable Patient Circuit that allows water to leak into the center gas lumen | Vapotherm, Inc. |
| Devices | Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. | Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN). | Class II | Disposable Patient Circuit that allows water to leak into the center gas lumen | Vapotherm, Inc. |
| Devices | Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system | Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN). | Class II | Disposable Patient Circuit that allows water to leak into the center gas lumen | Vapotherm, Inc. |
| Devices | Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. | Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN). | Class II | Disposable Patient Circuit that allows water to leak into the center gas lumen | Vapotherm, Inc. |
| Devices | Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision Flow system and Ikaria INOmax DSIR ® System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system | Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN). | Class II | Water may leak into the center gas lumen of the Patient Circuit | Vapotherm, Inc. |
| Devices | RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing. | Model #'s 66800059, all lots since product launched 01/16/2009 | Class II | Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification. | Smith & Nephew, Inc. |
| Devices | Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. | Lot: 75DD0406 | Class II | JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end of the knife cut. | Justright Surgical, LLC |
| Devices | Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge used when more than one firing is required during a surgery. | Lot: 75FD0417 | Class II | JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end of the knife cut. | Justright Surgical, LLC |
| Devices | The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. | Model numbers: 10281013, 10281163. | Class II | Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the wall stand. This error may result in line artifacts in the image. If these artifacts appear in the region of interest, the examination may need to be repeated. | Siemens Medical Solutions USA, Inc |
| Devices | Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates. | Lot Number: 14BMLB012 | Class II | Product was held at temperature above the labeled recommended storage temperature | Fresenius Medical Care Holdings, Inc. |
| Devices | DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra" Plate 3 Level / 57 mm part 04.613.257 lot 3693878 TI Vectra" Plate 4 Level / 64 mm part 04.613.364 lot 8143905 | TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra" Plate 3 Level / 57 mm part 04.613.257 lot 3693878 TI Vectra" Plate 4 Level / 64 mm part 04.613.364 lot 8143905 | Class II | DePuy Synthes is initiating a voluntary medical device recall of certain lots of the TI Vectra Plates, which is a part of the DePuy Synthes Vectra Anterior Cervical Plate Family of Systems. The Vectra Systems are intended for anterior screw fixation to the cervical spine (C2-C7). It was discovered in certain lots, that the clips are potentially missing from the TI Vectra Plates resulting in the inability to lock the screw onto the plates. | Synthes, Inc. |
| Devices | Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed | The same KIT PART Number
(PN 040-1458-00) identified on 12 units distributed IN the US and on 3
units distributed OUTSIDE of the US. These 15 units will receive
serial numbers after the software upgrade is installed. THERE ARE 70
SERIAL NUMBERS ON UNITS DISTRIBUTED IN THE US: 040-1548-00,
1367-000033, 1369-001517, ... More |
Class II | The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. The firm performed a retrospective analysis of all recalls since 2011 and discovered 222 additional serial numbers were missed and were not included in the previous recall under RES 59456 (recall number Z-3032-2011). | Spacelabs Healthcare |