MAY 2008

WEEK ENDING MAY 3

PRODUCT ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system:

a) Material Number 8245875; 

b) Material Number 8246951; 

c)  Material Number 8267697; 
CODE
a) Serial Numbers: 54602 56482 55620 53997 51959 56156 56192 56040 53614 56483 56651 56526 60018 60247 60348 60835 60870 60339 56577 53519 62170 59126 62257 60258 62370 63164 54043 63929-1 55706 56104 56124 56654 56922 57303 57380 57494 59024 59131 59174 59176 59221 60054 60057 60228 60237 60251 60254 60282 60285 60338 60438 60450 60460 60461 60601 60620 60625 60631 60633 60634 60645 60647 60661 60728 60860 60875 60880 60947 61043 61053 61067 61108 61114 61118 61120 61121 61123 61127 61212 61221 61225 61290 61422 61544 61661 61673 61745 61751 61771 61974 62040 62053 62057 62116 62128 62130 62132 62233 62240 62282 62396 62431 62543 62644 62738 62764 62790 62838 62840 62861 62871 62916 62924 63023 63097 63101 63103 63114 63115 63146 63165 63184 63196 63203 63205 63208 63337 63366 63368 63389 63408 63420 63455 63462 63468 63470 63566 63573 63690 63856 63862 63867 63878 63885 63886 63899 63928 64051 50970 51577 52356 52448 52565 52732 52743 52770 53437 53712 53725 54223 54549 54937 55091 55092 55156 55272 55734 54640 55197 53060 54446 54254 54423 54766 52071 52110 52427 53011 55012 54686 51080 52076 53357 54552 53467 54380 54688 52959 53932 52034 54121 52051 53446 50447 50834 50975 51048 51073 51571 52865 53252 53626 53631 53643 53844 53950 54065 54123 54317 54389 54521 54529 54546 54603 54934 54949 55082 55104 55135 55140 55441 55461 55838 55895 56355 57017 55351 55244 54315 54199 54366 51648 53978 51023 54489 54536 54808 50140 54130 53579 55553 50194 55853 53590 55477 53524 54958 63546 56823 56717 56758 56786 56196 55713 56123 56247 56248 56625 62755 50235 54425 53244 53803 50228 53182 54361 and 53990;
b) Serial Numbers: 62519 62835 63108 56191 and 54332;
c) Serial Numbers: 63168 61316 62848 63188 63275 and 63727
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Mountain View, CA, 
REASON Measurement Error affecting all Sequoia systems using the PAL video standard configuration and have a perspective PC installed: 1) The Sequoia" system is operating at a software revision below 8.0. 2) The Sequoia" system is configured to PAL video mode (normal for systems running at 240V 50 Hz.). 3) While using any of the Perspective" advanced display options listed above, an image or clip is then stored or saved to the system hard drive, MOD or a storage device. (This image or clip is known as a secondary capture.). 4) The secondary capture images/clips are subsequently recalled for review and measurements are made. If a measurement is taken on these secondary capture images/clips, an error can occur. The error is 0% if taken in the same axis that calibration was performed, and ranges proportionately up to 9% if the measurement is taken orthogonal or at right angles (90 degrees) to the axis that was used for calibration. If calibration was done on the horizontal axis, then vertical measurements are underestimated. If calibration was done on the vertical axis, then horizontal measurements are overestimated.
VOLUME OF PRODUCT IN COMMERCE 280 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
1) BIPAP AUTO, CORE PACKAGE NA, model number 1017442, filter, mask,
    and/or accessories for sleep therapy and ventilation devices, 
2) Filters under the following brand names: a) filter std incoming 7100 CPAP qty 1
    model number 1039618; b) filter reusable PLV 2/pkg model number 35220;
    c) LX UL Fine Filter 2 pack model number 1006193;
    d) RP-M Series Ultrafine Filters 6 pack model number 1029331;
    e) RP Vision OM Reg Filter (ASCO) model number 1007547;
    and f) REPL Filters package of 4 model number 929-4. Filter, mask, and/or
    accessories for sleep therapy and ventilation devices, 
3) Non-continuous ventilator accessories under the following brand names:
    a) Adult ECG Electrodes model number 1016360;
    b) O2 Enrichment Attachment BX 10 model number 312010;
    c) O2 Enrichment Attachment Single model number 312710;
    d) Alice 5, Domestic model number 1017226;
    e) BIPAP Auto M.W/Humid, W/SmartCard, CA model number CA701HS;
    f) BIPAP Auto M.W/Humid, W/SmartCard, US model number DS700HS;
    g) BIPAP Auto M, W/SmartCard, US model number DS700S;   
    h) BIPAP Auto SV W/SmartCard Dom Core model number 1040716;
     i) BIPAP Harmony, Intl model number 1012823;
     j) BIPAP Plus M, US model number DS600;
     k) BIPAP Plus M, W/Humid US model number DS600H;
     l) BIPAP S/T Core Pkg NA model number 1014248;
     m) BIPAP S/T North America model number 1012885;
     n) BIPAP Vision Filter Pack model number 582101;
     o) Duet LX/BIPAP Pro/Synch Pollen QTY 1 model number 1039611;
     p) FLXTB, 5 ½ inch STD, 22 mm, CE model number 1006042;
     q) FLXTB, 6 in Trach 15 mm taper, CE model number 1004968;
     r) GP UL-Fine Filter 2 pack model number 1006190;
     s) Incoming Filter 7000, 7001 CPAP model number 7070;
     t) Infant ECG Electrodes model number 1016361.
    Filter, mask, and/or accessories for sleep therapy and ventilation devices,
4) Inv Circuit Assembly Box 10 CE model number 652002. Filter, mask, and/or
    accessories for sleep therapy and ventilation devices, 
5) M Series Heated Humidifier Domestic model number 1022257. Filter, mask, and/or
    accessories for sleep therapy and ventilation devices, 
6) Mouthpiece, Angled 22mm CE model number FC06566. Filter, mask, and/or
    accessories for sleep therapy and ventilation devices, 
7) Omni Lab Core Domestic model number 1043343. Filter, mask, and/or accessories
    for sleep therapy and ventilation devices, 
8) PLV-102, 100V 50/60 HZ Japanese model number 87006. Filter, mask, and/or
    accessories for sleep therapy and ventilation devices, 
9) Power Cord Accessory under the following brand names: a) Power Cord W/C7 End
    Europe 5 ft model number 1039014 and b) Power Cord W/C7 End USA/CAN model
    number 1005894. Filter, mask, and/or accessories for sleep therapy and ventilation
    devices, 
10) Non-continuous ventilators accessories under the following brand names:
    a) REM Auto M. w/Humid, w/Smartcard A Flex US model number DSS10HS;
    b) REM Auto M. w/SC, w/Humid A Flex CAN model number CA511HS. Filter,
    mask, and/or accessories for sleep therapy and ventilation devices,
11) Non-continuous ventilator accessories under the following brand names:
      a) REMStar (Tower) Ultrafine Qty 1 model number 1036915,
      b) REMStar Auto M. w/Humid. w/Smartcard. US model number DS500HS;
      c) REMStar Auto M. w/Smartcard A FLEX US model number DS510S;
      d) REMStar Auto M. w/Smartcard, CNDA model number CA501S;
      e) REMStar Auto M w/Smartcard Intl model number IN501S;
      f) REMStar Auto M w/Smartcard US model number DS500S;
      g) REMStar Auto w/C-FLEX CANADA model number CA1017454;
      h) REMStar Auto w/C-FLEX Domestic Core Pkg model number 1017476.
      Filter, mask, and/or accessories for sleep therapy and ventilation devices,
12) REMStar Heated Humidifier Pkg model number 1005792. Filter, mask, and/or
      accessories for sleep therapy and ventilation devices
13) Non-continuous ventilator accessories under the following brand names:
      a) REMStar M US model number DS100;  
      b) REMStar M w/Humid US model number DS100H.
      Filter, mask, and/or accessories for sleep therapy and ventilation devices,
14) Non-continuous ventilator accessories under the following brand names:
      a) REMStar Plus M US model number DS200;
      b) REMStar Plus M w/Humid AHP model number AHP200H;
      c) REMStar Plus M w/Humid US model number DS200H;
      d) REMStar Plus M w/Humid, w/Smartcard, AHP model number AH200HS;
      e) REMStar Plus M w/Smartcard, US model number DS200S;  
      f) REMStar Plus w/C Flex Dom model number 1009586.
      Filter, mask, and/or accessories for sleep therapy and ventilation devices,
15) Non-continuous ventilator accessories under the following brand names:
      a) REMStar Pro2 Domestic model number 1020923;
      b) REMStar Pro M, w/Humid w/Smartcard US model number DS400HS;
      c) REMStar Pro M w/Smartcard US model number DS400S;
     d) REMStar Pro/Plus Silencer Cap model number 1005962;
      e) REMStar Pro/Plus/Auto/Lite Pollen model number 1005964;
      f) REMStar Pro/Plus/Auto/Lite Pollen SNGL model number 1001389;
      g) REMStar Pro/Plus/Auto/Lite Ultrafine model number 1005945;
      h) REMStar Pro/Plus/Auto/Lite Ultrafine Qty 1 model number 1039607.
     Filter, mask, and/or accessories for sleep therapy and ventilation devices,
16) Rotating Connector Packaged model number 302209. Filter, mask, and/or
      accessories for sleep therapy and ventilation devices, 
17) Non-continuous ventilator accessories under the following brand names:
      a) RP-L ComfortGel Cush and Flap model number 1031404;
      b) RP-M ComfortGel Cush and Flap model number 1031403. Filter, mask, and/or
          accessories for sleep therapy and ventilation devices, 
18) RP M Series Pollen Filter Kit 1 pack model number 1035443,  Filter, mask, and/or
       accessories for sleep therapy and ventilation devices,
19) Non-continuous ventilator accessories under the following brand names:
      a) RP-P ComfortGel Cush and Flap model number 1031391 and b) RP-S
          ComfortGel Cush and Flap model number 1031392. Filter, mask, and/or
          accessories for sleep therapy and ventilation devices,
20) Power Supply under the following brand names:
      a) RP, Power Supply Assembly model number H3600-015,
      b) RP, Wiring Harness, Lamp Holder model number H3600-020. Filter, mask,
          and/or accessories for sleep therapy and ventilation devices, 
21) RP-Assy, Cover, DC-5 pack model number F35933. Filter, mask, and/or
      accessories for sleep therapy and ventilation devices, 
22) Non-continuous ventilator accessories under the following brand names:
      a) RP-BIPAP Flow Pick-Up Tube Kit model number 332185;
      b) RP-BIPAP M Series Keypad model number 1038122; and
      c) RP-BIPAP Pro 2 /Plus Tubing Kit model number 1020358.
      Filter, mask, and/or accessories for sleep therapy and ventilation devices,
23) RP-Cable DC 6 w/Ring PLV RBL POR model number FC07270. Filter, mask,
      and/or accessories for sleep therapy and ventilation devices, 
24) RP C-Flex Mini Din Plug model number 1011220. Filter, mask, and/or accessories
      for sleep therapy and ventilation devices, 
25) Non-continuous ventilator accessories under the following brand names:
      a) RP-ComfortGel Gel Cushion M model number 1009050;
      b) RP-ComfortGel Gel Cushion P model number 1009048;
      c) RP-ComfortGel Gel Cushion S model number 1009049;
      d) RP-ComfortGel Silicone Flap L model number 1009109;
      e) RP-ComfortGel Silicone Flap M model number 1009054; and
      f) RP-ComfortGel Silicone Flap S model number 1009053.
      Filter, mask, and/or accessories for sleep therapy and ventilation devices,
26) RP Diaphragm Exhalation model number FC06372. Filter, mask, and/or
      accessories for sleep therapy and ventilation devices, 
27) RP Duet LX/Pro Out Port w/Seal model number 622239. Filter, mask, and/or
      accessories for sleep therapy and ventilation devices,
28) RP-Leaf, Check valve-5 pk model number F33440. Filter, mask, and/or
      accessories for sleep therapy and ventilation devices, 
29) RP-REM Auto w/C-FLEX/REM Pro Tubing Kit model number 1008492 and RP-
      REM Power Cord N. AMER model number 362524. Filter, mask, and/or
      accessories for sleep therapy and ventilation devices, 
30) RP-REMStar Plus Keypad model number 1006852. Filter, mask, and/or
      accessories for sleep therapy and ventilation devices, 
31) Continuous ventilator accessories under the following brand names:
      a) RP-Seal, Spring-5 pk model number F35465;
      b) RP-Seal, Greece, Ballscrew model number F35036;
      c) RP-Tub PVC 1/8 in x ¼ 50 ft model number 1008841;
      d) RP-Vision Filter Cover model number 1003444;
      e) RP-Vision RS-232 HRN ABV 106K model number 1004699; and
      f) RP-Wrap, Cord model number F35195.
      Filter, mask, and/or accessories for sleep therapy and ventilation devices,
32) APNEA monitor accessories under the following brand names:
      a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL model number 1025422;
      b) SM 2/2 PS Europe Patient Cable, Metal model number 1030194; and
      c) Smartmonitor 2 with modem, PCMCIA model number 4003.
      Filter, mask, and/or accessories for sleep therapy and ventilation devices,
33) Breathing Frequency Monitor Stardust 2 Domestic model number 1025720.
      Filter, mask, and/or accessories for sleep therapy and ventilation devices,
34) Non-continuous ventilators under the following brand names:
      a) Sync S/T Lab, w/o modem US/CAN model number 1010771;
      b) Sync S/T Lab, w/o modem US/CAN-RENT model number R1010771;
      c) Synchrony S w/o modem US/CAN model number 1002816;
      d) Tranquility Ultrafine Qty 1 model number 1039671; and
      e) Tubing Coupler model number 300065. Filter, mask, and/or accessories for
          sleep therapy and ventilation devices, 
35) Stardust Flexible Y Sensor Probe model number 612054. Filter, mask, and/or
      accessories for sleep therapy and ventilation devices, 
36) ECG Lead Set 60 in SOC to Snap model number 8049-1. Filter, mask, and/or
      accessories for sleep therapy and ventilation devices,
37) Oximeter Patient Cable Masimo 8 ft model number H5870. Filter, mask, and/or
      accessories for sleep therapy and ventilation devices, 
38) Oximetry Ear Clip Sensor model number 948. Filter, mask, and/or accessories for
      sleep therapy and ventilation devices, 
39) Lead Wire Pin/Socket 24 in 1 pr model number 9520. Filter, mask, and/or
      accessories for sleep therapy and ventilation devices,
CODE Lot Numbers 071010, 071011, and 071012
RECALLING FIRM/MANUFACTURER Respironics, Inc., Murrysville, PA,  
REASON Foreign material: Glass fragments may present in the plastic bag material used to ship components.
VOLUME OF PRODUCT IN COMMERCE 20,950 units
DISTRIBUTION Nationwide

 

PRODUCT CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Analyzer. Each package is identified with product description "CDS HGB SRNG W/BU", 
CODE All Hemoglobin Reagent Syringes, List No. 08H49-02, with packaging dates between May 8, 2007 and November 29, 2007
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Santa Clara, CA, 
REASON Count may be out of specification--Hemoglobin background count may be out of specification (high) after installation of new CELL-DYN Sapphire Hemoglobin Reagent Syringes with packaging dates between May 8, 2007 and November 29, 2007.
VOLUME OF PRODUCT IN COMMERCE 2,742 syringes
DISTRIBUTION Nationwide and Internationally

WEEK ENDING MAY 10

PRODUCT
a) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000, 
b) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator, Catalog Number: 255101; Product Number: M0062551010, 
c) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator, Catalog Number: 255102; Product Number: M0062551020, 
d) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog Number: 255103; Product Number: M0062551030, 
e) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog Number: 255104; Product Number: M0062551040, 
f) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator, Catalog Number: 255105; Product Number: M0062551050, 
g) Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Number: 255106; Product Number: M0062551060, 
h) Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46, Ureteral dilator, Catalog Number: 255108; Product Number: M0062551080, 
CODE
a) Lot numbers: W03-1606, W03-1649, , W03-1700, W03-1702, W03-1924, W03-2077, W03-2143, W03-2277, W03-2283;
b) Lot numbers: W03-1527, W03-1579, W03-1587, W03-1595, W03-1623, W03-1644, W03-1753, W03-1786, W03-1787, W03-1813, W03-1832, W03-1938, W03-2108, W03-2110, W03-2139, W03-2271, W03-2278, W03-2279, W03-2280, W03-2535, W03-2589;
c) Lot numbers: W03-1613, W03-1747, W03-1805, W03-1945, W03-2111, W03-2272, W03-2484, W03-2577;
d) Lot numbers: W03-1473, W03-1474, W03-1909, W03-2055, W03-2112, W03-2144, W03-2232, W03-2284, W03-2232, W03-2391, W03-2464, W03-2579;
e) Lot numbers: W03-1482, W03-1491, W03-1508, W03-1524, W03-1740, W03-1917, W03-2107, W03-2113, W03-2214, W03-2216, W03-2236, W03-2239, W03-2240, W03-2285, W03-2354, W03-2410, W03-2446, W03-2457, W03-2483, W03-2580;
f) Lot numbers: W03-1464, W03-1767, W03-2106, W03-2215, W03-2241, W03-2242, W03-2275, W03-2470, W03-2566;
g) Lot numbers: W03-2337, W03-2359, W03-2392, W03-2553, W03-2554, W03-2590;
h) Lot Number: W03-2341, W03-2357, W03-2395, W03-2578
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick, MA, 
Manufacturer: Onset Medical Corporation, Irvine, CA. 
REASON Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
VOLUME OF PRODUCT IN COMMERCE 1,998 units (total also includes Recall # Z-0912-2008 – Class III)
DISTRIBUTION Nationwide

PRODUCT
a) Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1, b) Siemens Coherence Therapist system, Part No: 7339125, medical charged-particle radiation therapy system with software version 2.1, 
c) Siemens Coherence Impression Therapist system, Part No: 7341410, medical charged-particle radiation therapy system with software version 2.1,
d) Siemens Primeview 3i medical charged-particle radiation therapy system, Part No: 7341428, with software version 3i, 
e) Siemens AG Therapist 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345411, 
f) Siemens Impression Therapist 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345429, 

g) Siemens Syngo based WS 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345437, 

h) Siemens Coherence Therapist 2.0 medical charged-particle radiation therapy system, Part No: 8139839, with software version 2.1, 
i) Siemens Primeview 3i 2.0 medical charged-particle radiation therapy system, Part No: 8139487, with software version 3i 2.0, 

j) Siemens Coherence Therapist 2.1 medical charged-particle radiation therapy system, Part No: 8147667, with software version 2, 
k) Siemens Primeview 3i 2.1 medical charged-particle radiation therapy system, Part No: 8147675, with software version 3i, 
CODE
a) Serial Numbers: 84601, 84602, 85703, 85714, 85718, 85720, and 00E0815479E1;
b) Serial Numbers: 10007, 10010, 10015, 10017, 10020, 10026, 10028, 10030, 10037,  10038, 10001, 10003, 10004, 10005, 10008, 10009, 10011, 10019, 10027, 10031,  10039, 11004, 11006, 10006, 10018 ,10021, 10022, 10024, 10025, 11005, 10016, 10023, 10029, 10032, 10033, 10035, 10036, 10040, 11001, and 11008;
c) Serial Numbers: 2801, 10201, 14101, 22201, 56302, 57401, 62701, 79102, 93301, 98001, 00E0815462E6, 00E08154754E, 00E081548949, 102001, 1601, and 39901;
d) Serial Numbers: 102301, 104201, 00E0815462E6, 5602, 48701, 57401;
e) Serial Numbers: 24801;
f) Serial Number: 735429;
g) Serial Numbers: 10017;
h) Serial Numbers: 10035, 10037, 15901, 10020, 10030, 10034, 10002;
i)  Serial Numbers: 10007, 10021, and 10014;
j) Serial Numbers: 10007, 10010, 10015, 10017, 10020, 10026, 10028, 10030, 10037, and 10038;
k) Serial Numbers: 3764, 10003, 10014, 10017, 10020, 10005, 10007, 10008, 10010, 10011, 10013, 10028, 10001, 10006, 10022, 10026, 10033, 10002, 10018, 10019, 10021, 10023, 10024, 10025, 10032, 10048
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions, USA, Inc., Concord, CA
REASON Image Orientation Incorrect (Image Shifts) - 1) if the reference image has been calibrated for centering and the reference image is used for patient positioning, the image will shift when the positioning tools are used. 2) This problem occurs only when non-square reference images are used, such as when images are cropped. At this point, the images will refresh, and the center of the reference image will shift.
VOLUME OF PRODUCT IN COMMERCE 118 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B,
CODE
Serial Numbers: 10483, 10651, 10628, 10488, 10605, 10676, 10658, 10421, 10685, 10724, 10584, 10619, 10626, 10629, 10635, 10694, 10706, 10438, 10600, 10668, 10655, 10436, 10606, 10702, 10433, 10558, 10636, 10642, 10692, 10698, 10412, 10440, 10539, 10613, 10674, 10621, 10634, 10583, 10684, 10476, 10414, 10664, 10671, 10712, 10472, 10567, and 10641
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, 
Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. 
REASON Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition system.
VOLUME OF PRODUCT IN COMMERCE 47 units
DISTRIBUTION Nationwide

PRODUCT Seradyn QMS Vancomycin reagents, Part Number: 0373589, 
CODE All lots (lots 501930, 502063, 502074, 600432, 601166, 601207, 602556, 603076, 603801, 603312, 700657 and 703027)
RECALLING FIRM/MANUFACTURER Seradyn, Inc., Indianapolis, IN
REASON False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.
VOLUME OF PRODUCT IN COMMERCE 1,819 kits plus bulk material for 1,863 kits
DISTRIBUTION Nationwide and Internationally

PRODUCT GE Centricity PACS RA1000 Workstation; for diagnostic image analysis, 
CODE Software versions 2.1.X. and 3.0.X
RECALLING FIRM/MANUFACTURER GE Healthcare Integrated IT Solutions, Barrington, IL
REASON Report missing characters: Four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [>], less than [<], quotation mark ["], and apostrophe [']). This may not be evident to the end user, as the symbols only appear when the Exam Note window is open.
VOLUME OF PRODUCT IN COMMERCE 423 units nationwide; 134 units internationally
DISTRIBUTION Nationwide and Internationally

PRODUCT Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, CODE Lots 05167CG2, 05192012, 05223012 and 06335012.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments Div. of Stryker Corporation, Portage, MI,
Manufacturer: Stryker Puerto Rico, Inc., Arroyo, PR. 
REASON Sterility may be compromised, as the packaging may have channels in the packaging seal.
VOLUME OF PRODUCT IN COMMERCE 25 boxes of 6
DISTRIBUTION Nationwide

PRODUCT Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Number: 255107; Product Number: M0062551070, 
CODE
Lot numbers: W03-2339, W03-2342, W03-2362, W03-2382, W03-2409, W03-2431, W03-2434, W03-2436, W03-2439, W03-2479, W03-2482, W03-2550, W03-2555, W03-2581, W03-2591
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick, MA, 
Manufacturer: Onset Medical Corporation, Irvine, CA. 
REASON Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
VOLUME OF PRODUCT IN COMMERCE 1,998 units (total also includes Recall # Z-0905/Z-0913-2008 – Class II Recalls)
DISTRIBUTION Nationwide

PRODUCT
a) Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1, Automated differential cell counter, Part Number: 626554,
b) Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software Version 2.2, Automated differential cell counter, Part Number 626553,
CODE
a) Serial numbers: AJ50363, AK25191, AK39273, AJ30194AK02009, AK24144, AJ32209, AL13073, AJ43303, AK32209, AJ50358, AL17100, AK24164, AJ47338, AJ13070, AL06029, AJ13071, AK32212, AK32210, AJ39264, AJ43304;
b) Serial Numbers: AL11058, AK20149, AJ37243, AJ08035, AK16130, AK01004, AJ33215, AK16129, AK25182, AK51355, AL13064, AJ38253, AK51353, AK07059, AL12062, AJ40271, AJ02008, AJ50371, AK07058, AL21134, AJ01002,
AK12093, AL15085, AL14077, AJ30191, AJ48342, AK20152, AK07060, AJ37246, AJ06026, AK32539, AJ39259, AL04022, AJ37240, AK48336, AJ46318, AJ14074, AJ17095, AK34227, AJ47331, AJ48341, AJ33210, AK48347, AK20158, AK12095,
AK16131, AK19146, AK17138, AJ25164, AJ24147, AJ51381, AJ48339, AK51359, AJ49351, AL14082, AL22140, AJ24155, AJ47332, AK51358, AL23144, AJ24151, AJ49348, AK51380, AJ38250, AK48343, AK17135, AK18141, AK09075, AK13103, AJ29184, AJ30189, AJ02006, AJ14075, AJ14073, AJ15079, AJ16087, AJ16085,  AJ15078, AJ16083, AJ19103, AJ19111, AJ21116, AJ19109, AJ21114, AJ21115, AJ21117, AJ22121, AJ22122, AJ23135, AJ25165, AJ24156, AJ25159, AJ24154, AJ25167, AJ25161, AJ47327, AK07062, AK33215, AL18108, AL20125, AJ17091,  AK34232, AJ25160, AJ25163, AK05025, AJ29181, AJ50366, AK48328, AJ44313,   AK51370, AK34230, AJ38248, AL19111, AJ12063, AJ44309, AJ22124, AK08071, AK48334, AK25177, AJ48344, AJ42294, AK51372, AL12063, AJ24158, AJ46319, AJ43298, AK30199, AK20153, AK51354, AJ31195, AJ49349, AJ12064, AK33225,
AJ35229, AK17140, AJ29183, AK16127, AJ36234, AK17134, AL09044, AJ48340, AK19147, AK39264, AL21133, AL06033, AJ19110, AJ10048, AK51361, AJ24148, AJ50368, AJ11056, AJ34221, AJ03012, AK19148, AK06051, AK34233, AK39246,
AJ14072, AJ44316, AJ42292, AK48338, AK34229, AJ29182, AK18139, AK08066, AK44284, AJ05020, AK30204, AK08063, AJ34217, AJ23129, AJ23134, AJ34226,
AJ37238, AK25181, AK34231, AK34228, AK34234, AK48342, AJ24142, AK39266, AJ47326, AL21135, AJ07032, AL16093, AJ38251, AJ38252, AJ43300, OAK48341,
AJ23138, AJ25166, AL23145, AK39273, AJ30194, AK02009, AJ24144, AJ32209, AL13073
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, 
Manufacturer: Applied Cytometry, Sheffield, UK. 
REASON Data generation error: If the cytosettings is not refreshed or restarted during data importation, the output will include old and new data.
VOLUME OF PRODUCT IN COMMERCE 516 units nationwide; 73 units in Canada
DISTRIBUTION Nationwide and Canada

PRODUCT Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, 
CODE Lot Number: G8677
RECALLING FIRM/MANUFACTURER
Recalling Firm: Straumann Usa, Llc, Andover, MA, 
Manufacturer: Instituit Strauman, Basel, Switzerland. 
REASON Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diameter) and therefore, will not fit into the NC implant (3.0mm diameter) narrow connection.
VOLUME OF PRODUCT IN COMMERCE 26 units
DISTRIBUTION Nationwide

WEEK ENDING MAY 17

PRODUCT Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product      Numbers 9012B1011 and 9012B1001, 
CODE No devices are being returned. The field action is being done to communicate and emphasize the current Instructions for Use (IFU) regarding detachment of the Capsule from the Delivery System.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, Manufacturer: Arizona Device Mfg., Tempe AZ. 
REASON Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall.
VOLUME OF PRODUCT IN COMMERCE 169,365
DISTRIBUTION Nationwide and Internationally

PRODUCT Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; Catalog Number: FHC-A202; Product Codes: FHC-A202-KFI3O & FHC-A202-KFI5O,
CODE
Lot Numbers: hCG6120203, hCG6120204, hCG7010080, hCG7010081, hCG7010038, hCG7010039, hCG7010040, hCG7030144, hCG7030145, hCG7030146, hCG7040076, hCG7040077, hCG7040078, hCG7040079, hCG7050121, hCG7050122, hCG7060073, hCG7060216, hCG7070042, hCG7070043, hCG7070044, hCG7007045, hCG7070060, hCG7070061, hCG7070186, hCG7070187, hCG7070191, hCG7080182, hCG7090049, hCG7090050, and hCG7090052
RECALLING FIRM/MANUFACTURER
Recalling Firm: Innovacon Inc., San Diego, CA,
Manufacturer: Abon Biopharm (Hangzhou) Co., Ltd, Hangzhou, Zhejiang, China. 
REASON Incorrect results; The Sure-Vue Serum/Urine hCG-STAT test, when interpreted at extended read times, may exhibit sensitivity to patient samples containing hCG at levels well below the cut-off, potentially resulting in a false positive interpretation by the user.
VOLUME OF PRODUCT IN COMMERCE 1,825,480 units
DISTRIBUTION Nationwide

PRODUCT ADVIA Centaur HAV lgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, 
CODE All lots
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions Diagnostics, East Walpole, MA
REASON Incorrect results; False reactive specimens on the ADVIA Centaur HAV lgM assay.
VOLUME OF PRODUCT IN COMMERCE 49,533 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) ev3 IntraStent Biliary Stent, Model Number: S10-26, Catalog Number: 90-0648-001,
b) ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16, Catalog Number: 90-0952-000, 
c) ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-26, Catalog Number: 90-0952-001, 
d) ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-36, Catalog Number: 90-0952-002. ev3 IntraStent DoubleStrut Peripheral Stent, Model Number: S11-36,
Catalog Number: 90-1075-002 (not approved within the USA), 

e) ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-16, Catalog Number: 90-1431-000. ev3 IntraStent LD DoubleStrut Large Diameter Peripheral Stent, Model Number: S15-16, Catalog Number: 90-1504-000 (not approved within USA), 
f) ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-36, Catalog Number: 90-1431-002. ev3 IntraStent LD DoubleStrut Large Diameter Peripheral Stent, Model Number: S15-36, Catalog Number: 90-1504-002 (not approved within USA), 
g) ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-16, Catalog Number: 90-2313-000 ev3 IntraStent LD Mega Large Diameter Peripheral Stent, Model Number: S17-16, Catalog Number: 90-2336-000 (not approved within    USA), 
h) ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-26, Catalog Number: 90-2313-001. ev3 IntraStent LD Mega Large Diameter Peripheral Stent, Model Number: S17-26, Catalog Number: 90-2336-001 (not approved within    USA),
i) ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-36, Catalog Number: 90-2313-002. ev3 IntraStent LD Mega Large Diameter Peripheral Stent, Model Number: S17-36, Catalog Number: 90-2336-002 (not approved within    USA), 
j) ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16,  Catalog Number: 90-2319-000. ev3 IntraStent LD Max Large Diameter Peripheral Stent Model Number: S18-16, Catalog Number: 90-2337-000 (not approved within    USA), 
k) ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-26, Catalog Number: 90-2319-001. ev3 IntraStent LD Max Large Diameter Peripheral Stent Model Number: S18-26, Catalog Number: 90-2337-001 (not approved within USA), 
l) ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-36, Catalog Number: 90-2319-002. ev3 IntraStent LD Max Large Diameter Peripheral Stent, Model Number: S18-36, Catalog Number: 90-2337-002. (not approved within USA), 

CODE
a) Lot Number: 2099706;
b) Lot Numbers: 2709041, 2537571, and 4493725;
c) Lot Number: 3604128;
d) Lot Numbers: 2418012, 2703169, and 1688108;
e) Lot Numbers: 2767839, 2715678, and 2790795;
f) Lot Numbers: 2722702, 2099726, and 1831865;
g) Lot Numbers: 3548016, 1940595, 1501170, 2417423, and 2313515;
h) Lot Numbers: 1646893, 1940629, 1940630, 2107072, 2293418, 2838055, 2563128, 2417407, 2829684, and 3293069;
i)  Lot Numbers: 1646894, 2107075, 2107080, 2703209, 1879156, 2417413, and 1695067;
j) Lot Numbers: 3766729 and 2417395;
k) Lot Numbers: 1879157, 1940667, 2429814, 2431937, 1646895, 3151708, 3104952, 2601011, 2107071, 2036017, 4206244, 2036018, and 2829735;
l) Lot Numbers: 1788817, 1940694, 1979985, 2356512, 1831905, 3170756, 2681547, 1940695, 2158549, 3182196, 3003378, 3013044, 1688027, 1688029, 3002623, 2968850, 1688030, 1688031, and 1979986
RECALLING FIRM/MANUFACTURER Ev3, Inc., Plymouth, MN, 
REASON Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
VOLUME OF PRODUCT IN COMMERCE 949
DISTRIBUTION Nationwide and Internationally

PRODUCT iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, 
CODE
iSITE PACS version 3.5x (Versions 3.5 and up to and including 3.5.65): 3.5.0.27, 3.5.0.36, 3.5.36.4, 3.5.38, 3.5.51.0, 3.5.51.02, 3.5.51.05, 3.5.56.0, 3.5.57.1, 3.5.57.2, 3.5.57.3, 3.5.57.4, and 3.5.65.0
RECALLING FIRM/MANUFACTURER Philips Healthcare Informatics, Inc., Foster City, CA,
REASON Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is still presented in the correct orientation next to the incorrect image when displayed on the monitor.
VOLUME OF PRODUCT IN COMMERCE 196 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 100 units of  heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection. The pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations:
    a) NDC #64253-333-35, catalog #MIH-3335: 5 mL fill in 12 mL syringe,
    b) NDC #64253-333-33, catalog #MIH-3333: 3 mL fill in 12 mL syringe,
    c) NDC #64253-333-23, catalog #MIH-3323: 3 mL fill in 6 mL syringe,
b) Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 10 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for
injection. The pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations:
    a) NDC #64253-222-35, catalog #MIH-2235: 5 mL fill in 12 mL syringe;
    b) NDC #64253-222-33, catalog #MIH-2233: 3 mL fill in 12 mL syringe,
c) Medefil Heparin I.V. Flush Syringe 1 unit/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 1 unit of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for
injection; The 5 mL fill in 6 mL syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton, NDC #64253-444-25, catalog #MIH-4425,
CODE
a) a) Catalog #MIH-3335: lot H107301, exp. date 09/09; H107305, exp. date 09/09; H107309, exp. date 10/09; H107313, exp. date 10/09; H107317, exp. date 10/09;  H107322, exp. date 10/09; H107340, exp. date 11/09; H108111, exp. date 12/09;
  H108116, exp. date 12/09; H108122, exp. date 01/10; H108127, exp. date 01/10;
    b) catalog #MIH-3333: lot H107332, exp. date 11/09; H108106, exp. date 12/09;  H108118, exp. date 12/09;
    c) catalog #MIH-3323: lot H108117, exp. date 12/09;
b) Catalog #MIH-2235: lot H07325, exp. date 11/09, H08113, exp. date 12/09; catalog #MIH-2233: lot H08124, exp. date 01/10;
c) Catalog #MIH-4425: lot H207335, exp. date 11/09
RECALLING FIRM/MANUFACTURER Medefil, Inc., Glendale Heights, IL, 
REASON The heparin lock flush solution was manufactured from contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API). The FDA has received reports of serious injuries and/or deaths in patients administered finished heparin injectable products manufactured from heparin API containing this contaminant.
VOLUME OF PRODUCT IN COMMERCE 3,713,040 syringes
DISTRIBUTION Nationwide

PRODUCT
a) Tyco Healthcare Monoject Prefill 10U/rnL Heparin Lock Flush Syringe, 10ml, REF # 8881580121, 
b) Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe, 3mL REF # 8881580123, 
c) Tyco Healthcare Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 5mL REF # 8881580125, 
d) Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 2.5mL in 3mL syringe REF # 8881580300, 
e) Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula REF # 8881581125, f) Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 10mL REF # 8881590121, 
g) Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 3rnL REF # 8881590123, 
h) Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe 5mL REF # 8881590125, 
i) Tyco Healthcare Monoject Prefill 100UlmL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula REF # 8881591125, CODE
a) Lot Numbers: 7082274; 7113214;
b) Lot Numbers: 7051524; 7113214;
c) Lot Numbers: 7051524; 7082274; 7113164; 7113174;
d) Lot Number: 7051444;
e) Lot Number: 7082274;
f) Lot Number: 7113064;
g) Lot Numbers: 7041194; 7072154; 7113034; 8010194;
h) Lot Numbers: 7041194; 7102804; 7041204; 7113034; 7051534; 7113044; 7051544; 7113054; 7051554 ; 7113104; 7071924 ; 7113114; 7072034; 7113154; 7072044; 8010064; 7072054; 8010114; 7072064 ; 8010134; 7072154; 8010174;
7082284;
i) Lot Number: 7082284;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Covidien LP, Mansfield, MA, 
Manufacturer: Covidien, Montreal, Quebec, Canada. 
REASON Scientific Protein Laboratories (SPL) disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient have a heparin-like contaminant.
VOLUME OF PRODUCT IN COMMERCE 11,054,950
DISTRIBUTION Nationwide

PRODUCT
a) Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210513. The product is shipped 4 units per shipping carton. Hemodialysis kit, 
b) Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210517. The product is shipped 4 units per shipping carton. Hemodialysis kit, 
CODE
a) Lot Number 07F06 exp 2012-05 and Lot Number 07G09 exp 2012-06;
b) Lot Number 07G04 exp 2012-06
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Allentown, PA, 
Manufacturer: B. Braun Carex SpA, Mirandola (MO), Italy.
REASON Faulty tubing does not prime machine as intended.
VOLUME OF PRODUCT IN COMMERCE 2,500 units
DISTRIBUTION Nationwide

PRODUCT Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, UPC Code: 30003-020917 and UPC Code: 30003-020917, 
CODE
Lot Numbers: 6G4890N, 7C0178N, 7D0529N, 7E1100N and 7F1816N;
Added 2/21/07 - Lot 7F2009N. 4-14-08: 6B2462N, 6E3474N, 6H5767N, 6J5972N and 6L7175N
RECALLING FIRM/MANUFACTURER
Recalling Firm: ConvaTec, Skillman, NJ, .
Manufacturer: Nypro Dominican Republic, Inc., San Cristobal, Dominican Republic. 
REASON Mislabeled: The market unit carton label reads 5/8 - 1 inch, and it should read 5/16 - 1 inch. The metric units (8-25mm) on the label are correct.
VOLUME OF PRODUCT IN COMMERCE 3,986 market units
DISTRIBUTION Nationwide

PRODUCT LIASON® 25-OH Vitamin D Kit, Vitamin D test system, Model Number 310900, 
CODE Lot Numbers: 120422 and 120423
RECALLING FIRM/MANUFACTURER Diasorin, Inc., Stillwater, MN, 
REASON Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high.
VOLUME OF PRODUCT IN COMMERCE 2,267 units
DISTRIBUTION Nationwide and Austria

PRODUCT
a) Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm, .070 in (internal dia), shaft length, 90 cm, Catalog Number: 34356-446, UPN H749343564460, Sterile EO, 
b) Boston Scientific Mach 1 peripheral Guide Catheter 6F, HS Hockey Stick, .070 in (internal dia), Shaft length 55cm, Catalog Number: 19-600, UPN M001196000, Sterile EO,
c) Boston Scientific Mach 1 peripheral Guide Catheter 6F, MP Multipurpose 90cm,  .070 in (internal dia), Shaft length 90cm, Catalog Number: 19-626, UPN M001196260, Sterile EO, 
d) Boston Scientific Mach 1 peripheral Guide Catheter 6F, RDC Renal double Curve, .070 in (internal dia), Shaft length 55cm, Catalog Number: 19-666, UPN M001196660, Sterile EO, 
e) Boston Scientific Mach 1 peripheral Guide Catheter 7F, MP Multipurpose, .081 in (internal dia), Shaft length 55cm, Catalog Number: 19-723, UPN M001197230, Sterile EO, 
f) Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in (internal dia), Shaft length 55cm, Catalog Number: 19-866, UPN M001198660, Sterile EO, 
CODE
a) Lot Number: 20022689;
b) Lot Number: 20025890;
c) Lot Numbers: 20034251 and 20025906;
d) Lot Number: 20030656;
e) Lot Number: 20030666;
f) Lot Number: 20039169
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick, MA, 
Manufacturer: Availmed S.A. de CV, Tijuana, Mexico. 
REASON Mislabeled: Seven lots/batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
VOLUME OF PRODUCT IN COMMERCE 94 units
DISTRIBUTION Nationwide and Internationally

Medtronic Initiates Recall for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass

Medtronic, Inc. today announced that it is initiating a recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. 

Limited lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). The patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time. 

In a separate action, Medtronic is advising customers that selected lots of Trillium-coated products were also manufactured with heparin containing OSCS. Trillium is another biosurface used on CPB products. The amount of heparin on the product is significantly lower than that contained on the Carmeda product. Medtronic's ultimate goal is to remove contaminated products from the market. However, based on the current data, the benefit of using the affected products outweighs any potential risk to patients. Since the maximum possible patient exposure to heparin from Trillium is extremely low, customers can continue to use the affected Trillium products until a replacement is available.

Patients with questions should talk to their physician. Physicians or Pefusionists with medical questions related to Medtronic therapies should contact Medtronic at 1-800-638 0218, Monday – Friday, 8:00 a.m. to 5:00 p.m. CDT

Atrium Initiates Recall Regarding HYDRAGLIDE™ Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery

Atrium Medical Corporation is recalling selected lots of HYDRAGLIDE™ Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). 

Customers with affected lots are advised to immediately discontinue use of these devices and obtain replacement catheters from Atrium. Atrium will be working with our customers to replace the affected product as soon as possible. If a non-elective procedure requires use of this catheter, we recommend that you do not use the catheter with either a cell saver autotransfusion system or direct autotransfusion chest drainage collection system for cardiopulmonary bypass surgery.

Physicians and hospital personnel with product related questions should call the company at 1-800-5-ATRIUM, Monday –Friday, 8:00 AM to 5:00 PM EST.

WEEK ENDING MAY 24

PRODUCT
a) VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version), 
b) VIASYS AVEA Ventilator, Catalog numbers: 17210-03 (Italian Comprehensive Version), 
c) VIASYS AVEA Ventilator, Catalog numbers: 17310-00 (USA Comprehensive Version), 
d) VIASYS AVEA Ventilator, Catalog numbers: 17311-00 (USA Standard Version),
e) VIASYS AVEA Ventilator, Catalog numbers: 17312-00 (USA Standard with Compressor Version), 
CODE
a) Serial numbers: AGV02302, AEV01757;
b) Serial numbers: AGV01472;
c) Serial numbers: AHV03020, AHV03021, AHV03022, AHV03023, AHV03024, AHV03025;
d) Serial numbers: AHV03000, AHV03001, AHV03004, AHV03005;
e) Serial numbers: AHV03066, AHV03040, AHV03041, AHV03042, AHV03043, AHV03044, AHV03045, AHV03046, AHV03047, AHV03049, AHV03095, AHV03096, AHV03097, AHV03098, AHV03099, AHV03100, AHV03101,   AHV03102, AHV03103, AHV03104, AHV03105, AHV03106, AHV03121, AHV03123, AHV03124, AHV03129, AHV03134, AHV03136
RECALLING FIRM/MANUFACTURER Viasys Respiratory Care, Inc. dba Bird Products, Palm Springs, CA
REASON Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.
VOLUME OF PRODUCT IN COMMERCE 41 units
DISTRIBUTION Nationwide and Internationally

PRODUCT AirLife Infant nCPAP System Driver (Catalog No: 006900;) a nasal continuous positive airway pressure device, which is part of a larger system that includes an Infant Nasal CPAP generator, fixation device and patient interface (prongs and/or mask); Firmware Version 2.02.39, 
CODE
Serial Numbers: 0107DL001, 0107DL002A, 0107DL003, 0107DL004A, 0107DL005, 0107DL006, 0107DL007, 0107DL008A, 0107DL009, 0107DL010, 0107DL011A, 0107DL012, 0107DL013, 0107DL014, 0107DL015, 0107DL016, 0107DL017, 0107DL018, 0107DL019, 0107DL020, 0107DL021, 0107DL022, 0107DL023, 0107DL024, 0107DL025, 0107DL026, 0107DL027, 0107DL028, 0107DL029, 0107DL030, 0206DL001, 0206DL002, 0206DL003, 0206DL004, 0206DL005, 0206DL006, 0207DL001, 0207DL002, 0207DL003, 0207DL004, 0207DL005, 0207DL006, 0306DL001, 0306DL002, 0306DL003, 0507DL007, 0507DL008, 0507DL009, 0507DL010, 0507DL011, 0507DL012, 0507DL013, 0507DL014, 0507DL015, 0507DL016, 0507DL017, 0507DL018, 0507DL019, 0507DL020, 0507DL021, 0507DL022, 0507DL023, 0507DL024, 0507DL025, 0507DL026, 0507DL027, 0507DL028, 0507DL029, 0507DL030, 0507DL031, 0507DL032, 0507DL033, 0507DL034, 0507DL035, 0507DL036, 0507DL037, 0507DL038, 0507DL039, 0507DL040, 0507DL041, 0507DL042, 0606DL001, 0606DL002A, 0606DL003, 0606DL004, 0606DL005, 0606DL006, 0606DL007, 0606DL008, 0606DL009A, 0606DL010, 0606DL011, 0606DL012A, 0606DL013, 0606DL014A, 0606DL015, 0606DL016, 0606DL017A, 0606DL018, 0606DL019A, 0606DL020, 0606DL021A, 0606DL022A, 0606DL023A, 0606DL024A, 0606DL025A, 0606DL026A, 0606DL027A, 0606DL028, 0606DL029, 0606DL030, 0606DL031, 0606DL032, 0606DL033A, 0606DL034, 0606DL035, 0606DL036, 0606DL037, 0606DL038, 0606DL039, 0606DL040, 0607DL043, 0607DL044, 0607DL045, 0607DL046, 0607DL047, 0607DL048, 0607DL049, 0607DL050, 0607DL051, 0607DL052, 0607DL053, 0607DL054, 0607DL055, 0607DL056, 0607DL057, 0607DL058, 0607DL059, 0607DL060, 0607DL061, 0607DL062, 0607DL063, 0607DL064, 0607DL065, 0607DL066, 0607DL067, 0607DL068, 0607DL069, 0607DL070, 0607DL071, 0607DL072, 0607DL073, 0607DL074, 0607DL075, 0607DL076, 0607DL077, 0607DL078, 0607DL079, 0607DL080, 0607DL081, 0607DL082, 0607DL083, 0607DL084, 0607DL085, 0607DL086, 0607DL087, 0607DL088, 0707DL089, 0707DL090, 0707DL091, 0707DL092, 0707DL093, 0707DL094, 0707DL095, 0707DL096, 0707DL097, 0707DL098, 0707DL099, 0707DL100, 0707DL101, 0707DL102, 0707DL103, 0707DL104, 0707DL105, 0707DL106, 0707DL107, 0707DL108, 0707DL109, 0707DL110, 0707DL111, 0707DL112, 0707DL113, 0707DL114, 0707DL115, 0707DL116, 0707DL117, 0707DL118, 0707DL119, 0707DL120, 0707DL121, 0707DL122, 0707DL123, 0707DL124, 0707DL125, 0707DL126, 0707DL127, 0707DL128, 0707DL129, 0707DL130, 0707DL131, 0707DL132, 0707DL133, 0707DL134, 0707DL135, 0707DL136, 0707DL137, 0707DL138, 0707DL139, 0707DL140, 1106DL001, 1106DL002, 1106DL003, 1106DL004, 1106DL005A, 1106DL006, 1106DL007A, 1106DL008, 1106DL009, 1106DL010A, 1106DL011, 1106DL012A, 1106DL013, 1106DL014A, 1106DL015A, 1106DL016, 1106DL017, 1106DL018, 1106DL019, 1106DL020, 1107DL133, 1107DL134, 1107DL135, 1107DL141, 1107DL142, 1107DL143, 1107DL144, 1107DL145, 1107DL146, 1107DL147, 1107DL148, 1107DL149, 1107DL150, 1107DL151, 1107DL152, 1107DL153, 1107DL154, 1107DL155, 1107DL156, 1107DL157, 1107DL158, 1107DL159, 1107DL160, 1107DL161, 1107DL162, 1107DL163, 1107DL164, 1107DL165, 1107DL166, 1206DL001A, 1206DL002A, 1206DL003A, 1206DL004A, 1206DL005A, 1206DL006A, 1206DL007A, 1206DL008A, 1206DL009A, 1206DL010, 1206DL011, 1206DL012A, 1206DL013A, 1206DL014, 1206DL015, 1206DL016A, 1206DL017, 1206DL018A, 1206DL019A, 1206DL020, 1206DL021, 1206DL022A, 1206DL023, 1206DL024, 1206DL025A, 1207DL167, 1207DL168, 1207DL169, 1207DL170, 1207DL171, 1207DL172, 1207DL173, 1207DL174, 1207DL175, 1207DL176, 1207DL177, 1207DL178, 1207DL179, 1207DL180, 1207DL181, 1207DL182, 1207DL183, 1207DL184, 1207DL185, 1207DL186, 1207DL187, 1207DL188, 1207DL189, 1207DL190, 1207DL191, 1207DL192, 1207DL193, 1207DL194, 1207DL195, 1207DL196, 1207DL198, and 1207DL199
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, Mc Gaw Park, IL,
Manufacturer: Cardinal Health 200 Inc dba Cardinal Health, Riverside, CA. 
REASON Oxygen fluctuations - The AirLife Infant Nasal CPAP System exhibited O2 fluctuations when used with low O2 flow rates when the PTO/Auxiliary port on the driver is used as a blender in administering O2 therapy via nasal cannula at flow rates of less than 4L/min.
VOLUME OF PRODUCT IN COMMERCE 314 units
DISTRIBUTION Nationwide

PRODUCT White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, 
CODE Lot Numbers: 51749i2, 51754i2 and 56675i2
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Santa Clara, CA, 
REASON Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.
VOLUME OF PRODUCT IN COMMERCE 3,499 bottles
DISTRIBUTION Nationwide and Internationally

PRODUCT Triathlon Baseplate Impactor Extractor, Orthopedic manual surgical instrument, Catalog Number 6541-4-805, Non-Sterile
CODE Lot: NYC08
RECALLING FIRM/MANUFACTURER Stryker Howmedica Osteonics Corp., Mahwah, NJ
REASON Insertion/Removal Difficulties: The Baseplate Impactor/Extractor may not assemble/disassemble easily to the baseplate.
VOLUME OF PRODUCT IN COMMERCE 293 units total
DISTRIBUTION Nationwide and Internationally

PRODUCT Syngo US Workplace Picture Archiving and Communication System, software version 2.0, 94043. Material number: 10035829,
CODE
Serial numbers: 250576, 260044, 260049, 260016, 250533, 250548, 250544, 250545, 250591, 250595, 250617, 700464562, 700465913, 700465914, 250565, 250557, and 250556
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions, Inc., Mountain View, CA
REASON Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed.
VOLUME OF PRODUCT IN COMMERCE 17 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-sterile/Reusable, 
CODE Lot Numbers: F58834, F60464, F60465 and F60466
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alcon Research, Ltd, Fort Worth, TX,
Manufacturer: Alcon Grieshaber AG, Schaffhausen, Switzerland. REASON Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction.
VOLUME OF PRODUCT IN COMMERCE 24 units
DISTRIBUTION Nationwide

PRODUCT AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08, 
CODE Lot Numbers: 59311P100 and 59312P100
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Abbott Park, IL,
REASON Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after installation of the revised assay file, VRTX error #0002 in Task 40 is generated and the instrument locks up when it attempts to report an AxSYM Amphetamine/Methamphetamine II patient result.
VOLUME OF PRODUCT IN COMMERCE 369 disks – Nationwide and 901 disks - Internationally
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 1-ml tube, Catalog Number: R8325102, 20/pack, 
b) Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 2-ml tube, Catalog Number: R8325106, 20/pack, 
CODE
a) Lot 518113;
b) Lot 521354
RECALLING FIRM/MANUFACTURER Remel Inc, Lenexa, KS,
REASON Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions.
VOLUME OF PRODUCT IN COMMERCE 500/1-ml. and 554/2-ml. packs
DISTRIBUTION Nationwide and Internationally

WEEK ENDING MAY 31

PRODUCT
a) Synchron LX20 Clinical Chemistry System, Part Numbers: 466200,473032,
b) Synchron LX20 PRO, Part Number 476100, 
c) Synchron LXi 725, Part Number A08357,
d) UniCel DxC 600 Part Number: A10405, 
e) UniCel DxC 600i, Part Numbers: A25638, A25639, 
f) UniCel DxC 600 PRO Part Number: A10400, 
g) UniCel DxC 800 Part Number: A10411, 
h) UniCel DxC 800 PRO Part Number: A10407, 
CODE All Serial numbers. All software versions
RECALLING FIRM/MANUFACTURER Beckman Coulter Inc, Brea, CA, 
REASON Intermittent Failure of Stirrer Motor-Beckman Coulter has determined that incorrect Glucose results on LX20 or DxC instruments have been related to an intermittent failure of the stirrer motor. -Stirrer motors can stall without any flags or motion errors. -If a stall occurs during a GLUm test near the time of sample inject, results may be affected. -Affected GLUm results may be high or low.
VOLUME OF PRODUCT IN COMMERCE 2,599 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 150 ml, Catalog no. A7526-150, in vitro diagnostic, 
b) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 450 ml, Catalog no. A7526-450, in vitro diagnostic, 
c) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 625 ml, Catalog no. A7526-625, in vitro diagnostic, 
d) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 504 ml, Catalog no. HA926-504, in vitro diagnostic, 
e) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 610 ml, Catalog no. HA926-610, in vitro diagnostic, 
f) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 7-A7526-R1-120, in vitro diagnostic, 
g) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 8-A7526-R1-120, in vitro diagnostic, 
h) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 305 ml, Catalog no. HA 726-305, in vitro diagnostic,
CODE
a) Lots 628302-005, 628302-059, 628302-085, 628302-086, 628302-087, 704601-087, 704601-130, 704601-131, 704601-134 and 704601-191;
b) Lots 628302-023, 628302-024, 628302-025, 628302-067, 628302-068, 704601-068, 704601-107, 704601-108, 704601-109, 704601-134 and 704601-166;
c) Lots 704601-068 and 704601-123;
d) Lot 704601-165;
e) Lots 628302-004 and 704601-113;
f) Lots 628302-025, 628302-346 and 704601-108;
g) Lots 704601-088, 704601-155 and 704601-165;
h) Lot 628302-045
RECALLING FIRM/MANUFACTURER Pointe Scientific, Inc., Canton, MI, 
REASON Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
VOLUME OF PRODUCT IN COMMERCE 955
DISTRIBUTION Nationwide and Internationally

PRODUCT Keeler All Pupil II Indirect Ophthalmoscope,
CODE
Serial numbers: 86249, 85806, 85598, 85601, 86390, 67321, 85600, 85697, 86372, 86394, 85599, 85602, 66378, 85814, 86392, 85605, 66886, 66708, 86255, 85565, 85556, 85558, 85562, 86370, and 66882
RECALLING FIRM/MANUFACTURER
Recalling Firm: Keeler Instruments, Inc., Broomall, PA, 
Manufacturer: Keeler Limited, Windsor, UK. 
REASON Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product.
VOLUME OF PRODUCT IN COMMERCE 25 units
DISTRIBUTION NJ

PRODUCT Clinical Chemistry ICT Calibrator, List Number: 1E46-02, 
CODE Lot Number: 0505017
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc, Irving, TX,
REASON Quality Control (Out of Range)- ICT Calibrator lot number: 0505017, may contain an interferent. Not all vials within a kit are affected. The investigation determined that the interferent affects Potassium (K+) only. Use of the affected calibrator vials will generate an acceptable, but low calibration slope. When Quality Control (QC) is run to verify the calibration, K+ QC results may be below acceptable QC ranges. This interferent does not affect Sodium (Na+) and Chloride (CL-).
VOLUME OF PRODUCT IN COMMERCE 1,377 units
DISTRIBUTION Nationwide and Internationally

PRODUCT MT-APSD-2.4 Type-@ Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposable non-sterile (43.2cm) standard perforated thermoplastic head, neck and shoulder mask (2.4mm), 1 device per package, 
CODE Lot Number: 34415
RECALLING FIRM/MANUFACTURER
Recalling Firm: Civco Medical Instruments Inc, Kalona, IA, 
Manufacturer: Med Tec Inc dba CIVCO Medical Solutions, Orange City, IA. 
REASON Mislabeled: The mask is mislabeled with the incorrect part number but the outer packaging is correct.
VOLUME OF PRODUCT IN COMMERCE 160 masks
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-805, 
b) Fiducial Markers (0.9 x 3 mm) Soft tissue gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-809,
CODE
a) Lot Number: 080117-01;
b) Lot Number: 080117-02
RECALLING FIRM/MANUFACTURER
Recalling Firm: Med Tec Inc dba CIVCO Medical Solutions, Orange City, IA, 
Manufacturer: C P Medical, Portland, OR. 
REASON Mislabeled: Fiducial markers were incorrectly labeled. They are marked (0.9x3mm cylindrical) Soft tissue gold markers, but contain (2mm spheres) Bone gold markers.
VOLUME OF PRODUCT IN COMMERCE 36/3-marker pouches spherical markers and 33/3-marker pouches cylindrical markers
DISTRIBUTION Nationwide

PRODUCT 9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; 
CODE Lot Numbers: W029275 and W029476.
RECALLING FIRM/MANUFACTURER Cardiac Science Corp, Bothell, 
REASON Adaptor Cable Incorrectly Manufactured: The red and white connector ends of the adapter are switched. Therefore, the cable will not connect to the electrodes as indicated in the instructions.
VOLUME OF PRODUCT IN COMMERCE 62 adaptors
DISTRIBUTION Nationwide