Enforcement Report for May 4, 2005

MAY 2005

WEEK ENDING MAY 7

PRODUCT
a) Endopath 5 mm Graspers with Ratchet Handles (product code 5DSG).
b) Endopath 5 mm Babcocks with Ratchet Handles (product code 5BB).
c) Endopath 10 mm Anvil Graspers with Ratchet Handles (product code 10AG).
d) Endopath 10 mm Babcocks with Ratchet Handles (product code 10BB).
e) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code FDC21.
f) FlexTrayTM EndopathÆ Cholecsystectomy Tray, CK141.
g) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code FDC24.
h) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW22.
i) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW42.
j) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW46.
k) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW49;
l) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW71S.
m) FlexTrayTM EndopathÆ GYN Tray, Kit code KD005.
n) FlexTrayTM EndopathÆ Gastric Tray, Kit code KDG05.
o) FlexTrayTM EndopathÆ Gastric Tray, Kit code KDG15.
p) FlexTrayTM EndopathÆ Appendectomy Tray, Kit code KNB12.
q) FlexTrayTM EndopathÆ Appendectomy Tray, Kit code KNB19.
r) FlexTrayTM EndopathÆ Gastric Tray, Kit code KNG05.
s) FlexTrayTM EndopathÆ Bariatric Tray, Kit code TBW70S.
t) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code FDC09.
u) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code FDC45.
v) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code TDC78S.
w) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code TDC86S.
x) FlexTrayTM EndopathÆ Gastric Tray, Kit code TGB01S.
y) FlexTrayTM EndopathÆ Gen. Laparoscopy Tray, Kit code TGL45.
z) FlexTrayTM EndopathÆ Gen. Laparoscopy Tray, Kit code TGL62.
aa) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC06.
bb) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC12.
cc) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC15.
dd) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC20.
ee) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC61.
ff) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC69.
gg) FlexTrayTM EndopathÆ Gastric Tray, Kit Code TNG42.
hh) FlexTrayTM EndopathÆ Gastric Tray, Kit Code TNG73.
ii) FlexTrayTM EndopathÆ Gastric Tray, Kit Code TNG89.
jj) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW30.
CODE
a) V41T3E, V4224V, V42415, V42621, V42675, V42756, V4285Y, V4297P, V42A37, V42E7H, V42G5L, V42H56, V42L17, V42L6A, V42P1C, V42R7C, V42R89, V42U6X, V42V2E, V42X00, V42Z6X, V43245, V4327Y, V43380, V43624, V43713 and samples;
b) V41T4F, V41W66, V41Y2L, V41Z4A, V4230C, V42553, V4272X, V42A8K, V42E42, V42G9Y, V42M4A, V42M4C, V42P7P, V42T67, V42V3N, V42X38, V4308K, V4333L and samples;
c) V42522;
d) V41P6R, V41T90, V41V1Y, V41W68, V4221A, V42468, V42757, V42A8J, V42D1U, V42F2A, V42J8K, V42L8X, V42N5V, V42U69, V42W21, V4323H, V42Z6W, V43554 and sample;
e) V4206M, V42863, V42Y5T, V4351F;
f) V4230R, V42N6G, V4346T;
g) V4276M, V42J4G, V43020, V4379J;
h) V41Y4D, V42646, V42N8A, V42VOU, V42X44;
i) V42E37, V42Y61;
j) V42215, V42F2E, V42N41, V42R8y, V4328D;
k) V41W5P, V41Y6U, V4293E, V42D2R, V42F21, V42Y06, V43029;
l) V42A83, V42R81, V42Z57, V4330Z;
m) V4290J, V42NOT, V4355L, V41W98;
n) V42P3A, V41W98;
o) V41R14, V42A8N, V2V5C, V4314E;
p) V42713, V42L31, V42E00, V42P25, V42X9Y;
q) V42X9Y, V42100, V4272Y, V42E6A, V42L52, V42P3T, V42X0R, V42Z5A, V4324J, V4355F;
r) V42P3A;
s) V42C31, V4340G;
t) V4276A, V420ED, V42J1N, V42M3D, V42V36, V42Z2R, V4314F;
u) V42C9U;
v) V4264H, V42G5K;
w) V42Y4E, V42Z55;
x) V42G87;
y) V41Y2R, V42A66, V42E3C, V42P37, V42R52, V4328E;
z) V4275R, V42A1E, V42H2V, V42T11;
aa) V42695, V42N43, V42R7K;
bb) V4274F, V42C8R, V42H24, V42R6H, V42W3D, V42Y8E, V4326J;
cc) V42162, V42J6X;
dd) V41Y30, V42858, V42R5E, V42U8R, V42Y01, V4372K;
ee) V42C8P, V42G43, V42X8N;
ff) V41X3K;
gg) V41T26, V42201, V42R3P, V42X4C, V4322J;
hh) V41T25, V42768, V42A65, V42F2D, V42H1U, V42N3Y;
ii) V42D70, V42X4A;
jj) V41U14, V4247A, V4292L, V42T4F, V42W45, V43096, V4361M.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon Endo-Surgery, Cincinnati, OH
Manufacturer: Ethicon Endo-Surgery, Inc. S.A. de C.V. Planta II, Ciudad Juarez, Chihuahua, Mexico. .
REASON Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.
VOLUME OF PRODUCT IN COMMERCE 70,119 devices.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Meridian Nexus, single use. Part Numbers: C4N00D001, 15867, 15880, 15880-30, 12000-1, 40000-1, 40200-1, 40301-1, 40301-1ML, 40301-1-13, 40301-1-13MM, 40301-1-24, 40301-1-30, 40302-1C24, 60000-1, 60201-1, 60300-M, 60301-1, 60301-1-24, 60302-1HM30-70, 60301-13042M, 72300-1-4-30-70, 72301-1, 72000-50-7589, 60301-1304042, and 72000-75.

b) Circuit-Unilimb, Pediatric, 1M (40"), Disposable, Clean Non-Sterile, Pediatric Anethesia Circuit, Part Number DYNJAPF4000.
c) Unilimb Circuit 40'' Bulk, single use Part Number 225-4400-300.
d) Meridian Nexus- Pediatric, single use Part Numbers 60211-1304042, 60111-1, 60111-1MN, 40111-13042, 15900,
40010-1, and 40111-1.
e) Portex Adult Single Limb Anesthesia Breathing Circuit, single use, Part Numbers: 386000 and 384001.
f) Circuit- Maching Kit, 40" Adult, 3L LPF, single use, Part Numbers RP640F0D0 and RP660F0D0.
g) Circuit-Nexus, Adult, single use, Part Numbers: N7A110CG06, N4A100CE06, C4N0121000, 60010-1B, and
40301-1-2730.
h) Coaxial Rebreathing Circuit 1.5 M and 2 M, single use, Part nubers T61500 (1.5 M) and T18116 (2 M).
i) Circuit-Unilimb, Adult, 1M (40"), Disposable, Clean Non-sterile, Adult Anesthesia Circuit,
Part Numbers DYNJAAF4000, DYNJAAF6225, and DYNJAAF6261.
CODE
a) Item Number 15867, Lot numbers: 562960904; 566590904; Item Number 15880, Lot numbers: 564360904, 566230904,
570181004, 571831004, 573201004, 573201004, 575401104, 575401104, 577011104, 577011104, 578951104, 581731104,
582631204, 588431204, 588431204, 589090105, 591180105, 591180105, 593360105, 596220105, 596220105, 597890105,
597890105; Item Number 12000-1, Lot Numbers: 581041104; Item Number 15880-30, Lot Numbers: 573401004;
Item Number 40000-1, Lot Numbers: 568891004, 571691004, 581071104, 585381204, 589170105, 591260105, 593990105,
594930105; Item Number 40200-1, Lot Numbers: 573461004, 573771004, 579661104; Item Number 40301-1, Lot Numbers: 584241204; Item Number 40301-1-13, Lot Numbers: 566290904, 569631004, 572811004, 574881104, 574881104, 578021104,
579671104, 585121204, 586721204, 588541204, 591330105, 593810105, 593810105; Item Number 40301-1-13MM, Lot Numbers: 569211004, 583381204; Item Number 40301-1-24, 20 per case, Lot Numbers: 564930904, 566300904, 571471004, 572821004, 574891104, 578081104, 580591104, 581691104, 583391204, 586731204, 588551204, 598410105;
Item Number 40301-1-30, Lot Numbers: 570781004, 593640105; Item Number 40301-1ML, Lot Numbers: 574901104,
594840105; Item Number 40302-1C24, Lot Numbers: 562980904, 566650904, 570791004;Item Number 60000-1, Lot Numbers: 591360105; Item Number 60201-1, Lot Numbers: 566370904, 568921004, 572491004, 573991004, 579691104, 581721104, 586761204, 590200105, 593860105, 595720105; Item Number 60300-1, Lot Numbers: 594760105; Item Number 60300-M, Lot Numbers: 568501004, 575711104; Item Number 60301-1-24, Lot Numbers: 581731104; Item Number 60301-13042M, Lot Numbers: 564510904, 568511004, 571951004, 573311004, 577181104, 580111104, 584431204, 586601204, 588621204, 589360105, 593490105, 596320105; Item Number 60302-1HM30-70, Lot Numbers: 565830904, 581791104, 585661204, 589370105, 590210105; Item Number 72000-50-7589, Lot Numbers: 583451204; Item Number 72000-75, Lot Numbers: 568521004, 571511004, 571961004, 574971104, 577191104, 578131104, 578131104, 582761204, 584961204, 593870105;
Item Number 72300-1-4-30-70, Lot Numbers: 564950904, 567821004, 572841004, 578141104, 580621104, 583471204,
586771204, 589380105, 591430105, 593880105, 597180105; Item Number 72301-1, 594880105; Item Number C4N000D001, 568751004, 574801104, 578781104, 586301204, 591060105, 593660105, 595620105, 596830105, 596950105;
Item Number 60301-1304042, Lot Number 597570105;
b) Lot numbers: 570591004, 578361104, 580661104, 583081204, 585451204, 589720105, 593720105;
c) Lot Numbers: 578221104, 583691204, 592220105;
d) Lot Numbers: 571671004; Lot Numbers: 568901004, 581081104; Lot Numbers: 575701104; Lot Numbers: 564430904, 580031104; Lot Numbers: 594870105; Lot Numbers: 569701004; Lot Numbers: 591400105;
e) Lot numbers: 551880804, 581451104, 581461104; Lot numbers: 551890804, 600080205, 5518908004;
f) Lot Numbers: 575951104, 596600105; Lot Number: 596610105;
g) Lot Number: 587021204, 587031204, 588371204, 591070105, 596840105; Lot Number: 575741104; Lot Number: 596700105; Lot Number: 564460904, 566310904, 568481004, 570271004, 571911004, 573261004, 577091104, 580061104, 582711204,
588561204, 589270105, 596290105; Lot Number: 575691104, 579871104, 585041204, 586291204;
h) Lot Number: 579811104; Lot Numbers: 572171004, 585301204;
i) Lot Number: 574481104; Lot Numbers: 570601004, 577491104, 578371104; Lot Numbers: 570701004, 589820105, 590030105, 593300105, 597460105.
RECALLING FIRM/MANUFACTURER
Recalling Firm: MMS Sales Corp, Pharr, TX
Manufacturer: CPM De Reynosa S.A. De C.V., Reynosa, Mexico.
REASON Partial occlusion in the T-piece resulting in airway obstruction.
VOLUME OF PRODUCT IN COMMERCE 161,273 units.
DISTRIBUTION Nationwide, Malaysia, Mexico, and New Zealand.

PRODUCT
a) Medline Custom Open Heart CDS Kit (non-sterile), reorder number CDS840144A, which contains Meridian Nexus
Unilimb Rebreathing Circuit, part 40301-1-30, among other components needed for open heart surgery;
b) Medline Custom Anesthesia Super Circuit Adult 60 Unilimb Kit (non-sterile), reorder number DYNJAAF6267; the kit
contains the Nexus Adult Unilimb Circuit -- 60", part 60010-1B, along with a 3 liter latex breathing bag, anesthesia tubing clip, suction catheter, adult anesthesia mask, suction canister, drawstring poly bag and poly bag.
c) Medline Custom Anesthesia Set Up Kit - Latex Free (non-sterile), reorder number DYNJAA0078C; the kit contains the Nexus Adult Unilimb Circuit -- 40", part C4N000D001, along with a 3 liter latex free breathing bag, suction catheter, adult medium anesthesia
mask, suction tubing, humid vent hme filter and poly bag.
d) Medline Custom Anesthesia Circuit Adult 40in Mask 3L Kit (non-sterile), reorder number DYNJAA4749; the kit contains the Nexus Adult Unilimb Circuit - 40", part C4N000D001, along with a 3 liter latex free breathing bag, adult medium anesthesia mask and poly
bag.
e) Medline Custom Anesthesia Circuit 40in Adult Unilimb Kit (non-sterile), reorder number DYNJAAF4304B; the kit contains the Nexus Adult Unilimb Circuit -- 40", part C4N012100, along with a 3 liter latex free breathing bag, gas sampling coestrud and poly bag.
f) Medline Custom Anesthesia Circuit 40in Adult Unilimb Kit (non-sterile), reorder number DYNJAA4315; the kit contains the Nexus Adult Unilimb Circuit - 40", part C4N012100, along with a 3 liter latex breathing bag, adult large anesthesia mask, gas line and poly bag.
CODE
a) Lots 04JD2847, 04LD2995, 05AD3946, 05BD0929, 05BD4100;
b) Lots 04LD1288, 04LD1865, 05CD0012, 05CD0467;
c) Lots 04KD3355, 04KD4186, 04KD4500, 04LD1866, 04LD2479, 04LD3673, 05AD3501, 05BD0357, 05BD4129;
d) Lots 04KD1031, 05AD1865, 05CD0210;
e) Lots 04LD2997, 05AD0061, 05AD1953, 05AD4630, 05BD2119;
f) Lots 04LD3310, 05AD0830.
RECALLING FIRM/MANUFACTURER Medline Industries, Inc, Waukegan, IL
REASON The procedure packs contain anesthesia/breathing circuits being recalled due to partial occlusion of the T-piece resulting in airway obstruction.
VOLUME OF PRODUCT IN COMMERCE 19,695 kits.
DISTRIBUTION CA, AL, MN, FL, and IN.

PRODUCT Staar Phaco Tubing Kit.
CODE Lot 08345.
RECALLING FIRM/MANUFACTURER Staar Surgical Co, Inc, Monrovia, CA
REASON Complaints of leaking with question of sterility and risk of infection in eye.
VOLUME OF PRODUCT IN COMMERCE 114 kits.
DISTRIBUTION CA, NV, UT, FL, and OR.

PRODUCT Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability.
CODE Serial numbers include 180053 180073 180076 180115 180136 180140 180145 180187 180204 180207 180221 180222 180224 180249 180255 180256 180260 180273 180274 180283 180294 180298 180311 180427 180433 180437 180448 180454 180458 180460 180463 180467 180469 180471 180473 180484 180486 180490 180491 180492 180509 180510 180512 180514 180517 180519 180522 180523 180526 180528 180541 180543 180549 180553 180554 180559 180560 180562 180566 180569 180576 180578 180581 180588 180593 180596 180597 180600 180601 180605 180606 180607 180608 180614 180618 180619 180626 180627 180629 180630 180631 180632 180633 180640 180643 180644 180645 180648 180655 180661 180668 180669 180670 180671 180672 180674 180679 180681 180683 180684 180690 180693 180694 180695 180696 180707 180709 180710 180715 180717 180718 180719 180720 180721 180724 180725 180726 180728 180729 180733 180735 180736 180737 180741 180745 180747 180750 180753 180756 180757 180758 180759 180761 180769 180777 180778 180780 180784 180785 180787 180792 180794 180795 180796 180797 180804 180810 180815 180816 180817 180821 180822 180823 180824 180825 180826 180827 180832 180831 180832 180833 180836 180837 180839 180841.
RECALLING FIRM Varian Medical Systems, Inc., Palo Alto, CA
REASON Treatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur.
VOLUME OF PRODUCT IN COMMERCE Approximately 170 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Cidexplus Solution Test Strips. Product Code: 2924, and Product Code: 2926.
CODE Lot Numbers: 011480, 011483, 011019; Lot numbers: 011283, 011020.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Advanced Sterilization Products, Irvine, CA
Manufacturer: Johnson & Johnson Medical, Ltd, Skipton, North Yorkshire, UK.
REASON CIDEX test strips were found to pass solution below MEC.
VOLUME OF PRODUCT IN COMMERCE 3,422 cases (2 bottles per case).
DISTRIBUTION Nationwide and PR.

PRODUCT
a) Vaxcel Low Profile Port with PASV Valve and 6F Polyurethane Catheter. CATALOG NO. 45-233. Ref. # M001452330.
b) Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. Catalog No. 45-236, Ref. # M001452360.
c) Vaxcel Low Profile Port with PASV valve and 8F Polyurethane Catheter. CATALOG NO. 45-238, Ref. # M001452380.
CODE
a) All lots as follows: 910022, 910022D, 923899, 973167 and 974706;
b) All lots as follows: 791486, 906776, 916194, 917025;
c) All lots as follows: 791484, 791485, 906777, 916195, 916196, 916197, 917026, 918870, 919481, 920550, 921765,
and 924851D.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick, MA.
Manufacturer: Boston Scientific Corp., Glens Falls, NY.
REASON Potential separation of the port base from the port cover after implantation.
VOLUME OF PRODUCT IN COMMERCE 1,217 units.
DISTRIBUTION Nationwide and South Africa.

PRODUCT Architect Folate Reagent Kit, list 6C12-20 (4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests).
CODE Lot numbers: 21082M200, 22024M100, 21082M201, 22024M101, 16603M200, and 22025M100.
RECALLING FIRM/MANUFACTURER Abbott Laboratories MPG, Abbott Park, IL
REASON Concentrations for normal samples generated with current reagent lots of the Architect Folate assay are lower than data generated for the package insert.
VOLUME OF PRODUCT IN COMMERCE
1,419 -- 4 x 100 test kits,
742 -- 100 test kits,
575 -- 4 x 500 tests.
DISTRIBUTION Internationally.

PRODUCT DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitis A Virus (IgM anti-HAV) in Human Serum or Plasma Catalog No. P001925.
CODE 9850180E (expiration 08/02/2005); 9850180E/1 (expiration 08/02/2005); 9850180F (expiration 08/02/2005) and 9850190A (expiration 01/18/2006).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diasorin Inc., Stillwater, MN
Manufacturer: DiaSorin S.p.A. Saluggia, Italy.
REASON The package insert for Hepatitis A Virus IgM antibody kit (ETI-IgMK Plus, catalog P001925), may inadvertently contain pages 5 through 12 from the instructions for Hepatitus A virus Total antibody test (ETI-AB-HAVK Plus, catalog P001926).
VOLUME OF PRODUCT IN COMMERCE 2,104.
DISTRIBUTION Nationwide and PR.

PRODUCT Configuration Transfer Cable; an accessory for the Colleague Infusion pump, Product code 2M8155. .
CODE Batch #50604.
FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL
Manufacturer: Valcom, Inc, Las Vegas, NV.
REASON The Configuration Transfer Cable for the Colleague Infusion Pumps has incorrect thumb screws on it, not allowing firm connections of the cable to the pump to transfer data to the biomedical engineer's diagnostic device.
VOLUME OF PRODUCT IN COMMERCE 404 cables.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960.
CODE Lot # 041207T, expiration date: 9-30-2005.
RECALLING FIRM
Recalling Firm: Diasorin, Inc., Stillwater, MN
Manufacturer: Phoenix Bio-Tech Corp., Mississauga, Ontario, Canada.
REASON Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be diluted to one liter.
VOLUME OF PRODUCT IN COMMERCE 14.
DISTRIBUTION MA, CA, TX, KS, NY, and FL.

WEEK ENDING MAY 14

MRL, Inc. a Welch Allyn Company Issues a Voluntary Worldwide Recall of Selected AED20 Automatic External Defibrillators

MRL, Inc., a Welch Allyn Company, today announced it is initiating a voluntary worldwide recall of 597 AED20 Automatic External Defibrillators manufactured in Buffalo Grove, IL between February and July of 2004. The AED20 may display a “Defib Comm” error message on the device display during use resulting in a failure of the device to analyze the patient’s ECG and deliver the appropriate therapy which prevents the defibrillator from resuscitating a patient. This problem occurs when an impact to the exterior of the AED20 causes a circuit board connector to perforate an insulation shield enabling an electrical short between the connector and the external housing of the AED20.

MRL, Inc initiated notification via certified mail on May 5, 2005 to its customers who purchased AED20’s in this group of devices (296 of which were sold within the US and 301 outside of the US). The company is providing customers with a loaner AED20 at no cost while their unit is being serviced and will pay all costs associated with shipping, handling and corrective service.

Customers with questions may contact the company at 1-800-462-0777 for more information.

PRODUCT Sunrise Hoyer Advance Hydraulic and battery powered Patient lifts.
a) Model: Hoy-Advance-E;
b) Model: Hoy-Advance-H.
CODE
a) Serial Numbers: 0409L2383, 0409L2384, 0411L001-0411L0023;
b) Serial Numbers: 0409L2341-0409L2380, 0410L0680-0410L0727, 0410L0781-0410L0862.
RECALLING FIRM/MANUFACTURER Sunrise Medical, Inc., Longmont, CO
REASON The leg actuation mechanism on certain Hoyer Advance Patient Lifts may not operate properly, which could cause the lift to become unstable.
VOLUME OF PRODUCT IN COMMERCE 27 units.
DISTRIBUTION WI, FL, GA, TX, OK, and Canada.

PRODUCT VersaRad Generator.
CODE Generator S/Nís: 9918-0704-002; 9918-0804-003; 9918-0804-007; 9918-0804-005; 9918-0204-001; 9918-0304-001; 9918-0304-003; 9918-03304-004; 9918-0505-002; 9918-0604-001; 9918-0604-003; 9918-0604-006; 9918-0704-001; 9918-0704-003; 9918-0704-004; 9918-0704-005; 9918-0803-002; 9918-0804-002; 9918-0903-002; 9918-1003-001; 9918-1203-002; 9918-0604-007; 9918-0804-004; 9918-0404-002; 9918-0803-001; 9918-0504-003; 0304-002; 0404-003; 0504-004; 9918-0604-005; 9918-0903-001; 9918-0404-001; 9918-0604-002; 9918-0504-001; 9918-0804-001; 9918-1103-001; 9918-1203-001; 9918-0604-004.
RECALLING FIRM/MANUFACTURER Fisher Imaging Corporation, Denver, CO
REASON Some VersaRad Systems have a faulty weld that may result in oil leakage.
VOLUME OF PRODUCT IN COMMERCE 38 units.
DISTRIBUTION Germany, Greece, Italy, Kuwait, Spain, Sweden, and Switzerland.

PRODUCT
a) Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; 12 units per case; Schein product code 629-6426, Model AM-BIO-65 ‚ 1.3 m2 surface area, Schein product code 629-3146, Model AM-BIO-75 ‚ 1.5 m2 surface area,
Schein product code 629-0041, Model AM-BIO-100 ‚ 2.0 m2 surface area.
b) Asahi AM-BIO-HX Extended Range Series Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory
with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; 12 units per case; Schein product code 629-6404,Model AM-BIO-HX-75 ‚ 1.5 m2 surface area and Schein product code 629-8540, Model AM-BIO-HX-100 ‚
2.0 m2 surface area.
c) Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; 12 units per case; Schein product CODE 629-4923, Model APS-21R - 2.1 m2 surface area.
d) Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (23 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; 24 units per case; Schein product code 629-9041, Model CL*E12NLA - 1.2 m2 surface area, Schein product code 629-5978, Model CL*E15NLA ‚ 1.5 m2 surface area, Schein product code 629-1824, Model CL*E18NLA - 1.8 m2 surface area and Schein product code 629-7278, Model CL*E20NLA ‚ 2.0 m2 surface area. e) Terumo Clirans Series EE Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (28 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; 24 units per case; Schein product code 629-3169, Model CL*EE12NLA - 1.2 m2 surface area, Schein product code 629-8232, Model CL*EE15NLA ‚ 1.5 m2 surface area and Schein product code 629-5106, Model CL*EE20NLA - 2.0 m2 surface area.
CODE
a) Lot numbers 04191H, 044A4T, 0419H4A4T; Lot numbers 044L54, 046Q73, 044L546Q73; Lot numbers 044J53, 04616X, 04616X626Y, 04626Y, 04626Y636B, 04636B, 04636B696K, 04696K, 046F6Q, 046F6Q6L6S, 046H6S, 046L6S, 046L6S6M6V, 046M6V, 046M6V6P72, 046P72, 046Q73;
b) Lot number 047F7S; Lot numbers 04454F, 045Z5L, 045Z5L5A5N, 045A5N, 045A5N5B5P, 045B5P, 045B5P5Q5W,
045Q5W, 045S64, 045T69;
c) Lot numbers U4383Y, U4383Y8K8N, X46R6V, W4797A, W4797A7X7B, X47X7B, X47X7B7Q7U, W47Q7U, W47Q7U7R7U,
W47R7U, W48K8N;
d) Lot numbers 040408, 0404080511, 040511, 0405110610, 040610, 040909; Lot numbers 040406, 0404060511, 040511;
Lot numbers 031020, 0310201215, 031215; Lot numbers 020604, 0206040711, 020711;
e) Lot number 040116; Lot number 031212; Lot numbers 031128, 0311281223, 031223.
RECALLING FIRM/MANUFACTURER Asahi Medical Co. Ltd, Chiyoda Ku, Japan
REASON Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.
VOLUME OF PRODUCT IN COMMERCE 174,587 units.
DISTRIBUTION Nationwide and Puerto Rico.

PRODUCT Stryker brand Birthing Bed; Model 4701.
CODE All units manufactured October 18 through November 5, 2004.
RECALLING FIRM Stryker Medical, Kalamazoo, MI
REASON Trendelenburg and reverse trendelenburg features may not function.
VOLUME OF PRODUCT IN COMMERCE 31 beds.
DISTRIBUTION Ca, GA, IN, IA, MI, OH, and PA.

PRODUCT Axiom Artis X-Ray System using software version VB11D or VB20B.
CODE Model numbers 5904433, 5904441, 5904466, 7007755, 7008605, 7412807, 7413078, 7555365, 7555373, 7727717, and 7728350.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA
Manufacturer: Siemens Medical Solutions, Erlangen, Germany.
REASON Live display in exam room may sporadically stop working although the display in the control room remains fully operational.
VOLUME OF PRODUCT IN COMMERCE 295 units.
DISTRIBUTION Nationwide.

PRODUCT Altaire, Magnetic Resonance Imaging Device.
CODE Serial numbers: L001 to L212.
RECALLING FIRM/MANUFACTURER Hitachi Medical Systems America, Inc., Twinsburg, OH
REASON The electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard.
VOLUME OF PRODUCT IN COMMERCE 212 devices.
DISTRIBUTION Nationwide.

PRODUCT Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, 12 treatments.
CODE Lot #251478-003.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Selectivemed Components, Inc., Mount Vernon, OH
Manufacturer: MRP, Inc., Monticello, IN.
REASON The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed.
VOLUME OF PRODUCT IN COMMERCE Approximately 2,600 units.
DISTRIBUTION CA.

PRODUCT Baxter Spinal Anesthesia Trays; sterile, single use only procedure trays that contain BD 25 G x 8.9 cm (3-1/2î) Whitacre Spinal Needles.
CODE Product code 1T2156, lots GD809251, GD809582; product code 1T2352, lot GD810325; product code 1T2356, lots GD809152, GD810333; product code 1T2450, lot GD809590; product code 1T2451, lot GD801282; product code 1T2456, lots GD810564, GD808519, GD800516, GD804492, GD805960, GD812024, GD810861, GD806323, GD810366, GD806620; product code 1T7457, lots GD810911, GD809624; product code 2T0086, lot 809335; product code 2T0188, lot GD812255; product code 2T0298, lot GD809632; product code 2T0310, lot GD809640; product code 2T0329, lot GD809657; product code 2T0341, lot GD808642; product code 2T0378, lot GD809673; product code 2T0455, lots GD810614, GD809699; product code 2T0458, lot GD811448; product code 2T0555, lots GD810622, GD809400; product code 2T0618, lot GD811182; product code 2T0642, lots GD810655, GD808931; product code 2T0643, lot GD811455; product code 2T0661, lots GD808956, GD809434; product code 2T0770, lot GD810275; product code 2T0783, lot GD810101; product code 2T0784, lot GD809830; product code 2T2001, lot GD810788; product code 2T2007, lots GD810416, GD812156; product code 2T2008, lot GD809467; product code 2T2011, lot GD811737; product code 2T2014, lots GD809475, GD811026; product code 2T2022, lot GD808683; product code 2T2023, lot GD808311; product code 2T2025, lots GD811471, GD810127; product code 2T2108,lot GD809004; product code 2T2226, lot GD810721; product code 2T2230, lots GD811059, GD808360; product code 2T2287, lot GD809491; product code 2T2342, lots GD811117, GD808410.
FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL
Manufacturer: Baxter Healthcare Corp., Cleveland, MI.
REASON The anesthesia trays contain BD 25G Spinal Needles which have leakage at the plastic hub of the needle.
VOLUME OF PRODUCT IN COMMERCE 127,340 trays.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Sentinel Implantable Cardioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a
programmable Hot Can electrode and bradycardia pacing support.
b) Sentinel Implantable Cardioverter-DefibrilIator (ICD) model 2012 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a
programmable Hot Can electrode and bradycardia pacing support.
CODE
a) AK630187, AK630131, AK630076, AK630290, AK630173, AK630115, AK730368, AK630130, AK630167, AK630099,
AK630106, AK730377, AK730393, AK730443, AK730363, AK630157, AK730442, AK630026, AK630135, AK630102,
AK630226, AK630142., AK730431, AK630185, AK630137, AK630230, AK630147, AK630015, AK630030, AK630197,
AK630098, AK730448, AK630090, AK630265, AK630160, AK730455, AK730381, AK630146,
OUS codes: AK630029, AK630043, AK630045, AK630046, AK630048, AK630055, AK630066, AK630067, AK630069,
AK630072, AK630073, AK630075, AK630078, AK630080, AK630083, AK630101, AK630104, AK630108, AK630111,
AK630112, AK630121, AK630129, AK630154, AK630155, AK630172, AK630174, AK630175, AK630178, AK630186,
AK630199, AK630207, AK630216, AK630221, AK630223, AK630231, AK630247, AK630280, AK630281, AK630283,
AK630284, AK630296, AK630297, AK630298, AK630299, AK730435, AK730439, AK730441;
b) BE650129, BE650026 and BE650027. OUS: BE650038 and BE650002.
RECALLING FIRM Ela Medical Llc, Plymouth MN
REASON A change in the automatic capacitor reform schedule during the later portion of the deviceís useful life can result in excessive 750V charge times and disable the deviceís ability to report an End of Life (EOL) indicator due to excessive charge times unless the patient is receiving periodic 750V therapy shocks.
VOLUME OF PRODUCT IN COMMERCE 59 within US and 49 OUS.
DISTRIBUTION Nationwide, UK, Italy, Germany and Argentina.

PRODUCT
a) e-fix E19 power drive. The product is a wheelchair component/accessory.
b) e-fix E20 power drive. The product is a wheelchair component/accessory.
CODE
a) Model number E19;
b) Model number E20.
FIRM/MANUFACTURER
Recalling Firm: Frank Mobility Systems, Inc., Oakdale, PA
Manufacturer: Ulrich-Alber Gmbh, Albstadt Tailfingen, Germany.
REASON Product may short circuit within the interface due to long term exposure of liquid.
VOLUME OF PRODUCT IN COMMERCE 314 units.
DISTRIBUTION Nationwide, Mexico and Panama.

PRODUCT Stryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 375-951-000.
CODE The following part numbers and subsequent lot numbers are involved in this recall. Part number 0275-950-000: 04109232, 0419292, 04109312, 04119712, 04119732, 04363AG2, 04364AG2. Part number 0275-951-012: 04098532, 04098752, 04098852, 04098872, 04109172, 04109212, 04109292, 4109312, 04119352, 04119392, 04119432, 04119712, 04129892,04129912, 04355AG2, 04357AG2, 04358AG2, 04363AG2. Part number 0275-951-012S1: 4098812, 04119672. Part number 0275-951-200: 04098492, 04362AG2. Part number 0275-952-000: 04108972, 04113432, 04129812, 05013AG2. Part number 0375-950-000: 0409522, 04112882, 04112962, 04123162. Part Number 0975-950-012: 04102542, 04102662, 04123162, 04123202. Part number 0375-951-012: 04092262, 4092362, 04092402, 04112862, 04112882, 04112902, 04113042, 04113082, 04123142, 04123202. Part Number 0375-951-200: 04113042. Part number 0275-950-012: 04098812, 04108912, 04109152, 04119512, 0411612, 0411712, 04129792, 04357AG2. Part Number 0275-951-000: 04098532, 04098552, 04098752, 04098772, 04098832, 04098852, 04098892, 04108912, 04109152, 04109172, 04109192, 04109232, 04109252, 04109292, 04119412, 04119432, 04119612, 04119632, 04119712, 04119732, 04129792, 04129852, 04129912, 04129972, 04352AG2, 04352AG2. Part Number 0375-951-000: 04092262, 4092362, 04102542, 04102662, 04102682, 04102762, 04112882, 04113002, 04113082, 04123162, 04123202, 04123222. Part number 0375-952-000: 04092522, 04102602, 04113042, 04123222.
RECALLING FIRM/MANUFACTURER Stryker Endoscopy, San Jose, CA,
REASON The device has the potential to overheat and cause patient burns during use.
VOLUME OF PRODUCT IN COMMERCE 28935 units (5 units per box).
DISTRIBUTION Nationwide.

PRODUCT MedRo Rx ‚ Reverse Osmosis System All Models All Voltages. Models: MRORXO1, MRORXO2, MRORXO3,MRORXO4, MRORXO5, MRORXO6, MRORXO8,MRORXO9, MRORX12. CMRORX01, CMRORX02, CMRORX03, CMRORX04, CMRORX05, CMRORX08.
CODE Serial Numbers: 53130 through 60754 (not consecutive).
RECALLING FIRM/MANUFACTURER
Recalling Firm: U.S. Filter/Ionpure, Inc., Lowell, MA
Manufacturer: U.S. Filter Water Process Inc, Colorado Springs, CO.
REASON Incorrect type of stainless steel firm used 303 vs 316.
VOLUME OF PRODUCT IN COMMERCE 275 units.
DISTRIBUTION Nationwide, Canada and Mexico.

Biomerieux Issues New Alert on the Recall of Certain Lots of Its Simplastin Tissue Reagent Used in Laboratory Monitoring of Oral Anticoagulant Therapy

BioMerieux Inc., of Durham NC, is issuing a new alert on a recall of Simplastin HTF, a tissue thromboplastin reagent that is used in laboratory diagnostic testing of patients receiving anticoagulant testing. The new alert is being issued because mislabeling problems with certain lots of this product could result in inaccurate test results, which in turn could lead to improper patient treatment – in some cases resulting in serious or life-threatening injury.

The recalled product can be identified by product catalog number 259846, lots 161798, 161764, and 161763 or catalog number 259847, lots 161849 and 161800. The recalled lots were distributed worldwide, including 236 customers in the U.S. Laboratories that have this reagent should not use it, but instead contact the company. Laboratories who have used this reagent should also contact any physicians or medical institutions whose patients may be affected by this problem.

BioMerieux Inc. is notifying its distributors and subsidiaries by Field Corrective Action communication and has notified all customers individually about the change in the recall’s status.

Customer with questions may contact the company at 1 800 682 2666 or their local BioMerieux, Inc. customer representative. Patients or healthcare providers with concerns about this issue can also call the company at this number.

WEEK ENDING MAY 21

***CORRECTION****
The recall product is the CM 100-Headstart Adapter Cable, Cat. No. 920650 (not Laerdal Medical Corp, CM 100-HeadStart® Automatic External Defibrillator Adapter Cables). The recalled Adapter Cables are for use with the Laerdal Heartstart 4000 and various Philips models listed. The Laerdal Heartstart 3000 is not involved or affected by this recall. It should not be included. The subject Adapter Cable cannot be attached to a Heartstart 3000.
Customers are instructed to discontinue use of the Adapter Cables, and to order alternative cabled electrodes that do not require adapters (not alternative cables) from Philips Medical Systems. The recalling firm is Laerdal Medical, not Volex Inc., and Laerdal’s firm initiated recall is ongoing.

PRODUCT LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction defibrillator pads to be used with the HeartStart 3000 and 4000 series defibrillators and Philips Medical Systems CodeMaster 100 and XL series defibrillators. The Adapter Cable is supplied to customers as an independent accessory and is sold in a clear poly bag with a white stick on label that reads "PART # 920650 ADAPTER CM100/LMC ELECTRODE". There is no other labeling and no directions for use that accompany the product. The Adapter Cable is also included as a component of the CodeMaster 100 Accessory Pack.
CODE All lots.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Laerdal Medical Corporation, Wappingers Falls, NY
Manufacturer: Volex Inc., North Dartmouth, MA.
REASON Incidents of wire breakage in adapter cable resulting in inability to operate the defibrillator.
VOLUME OF PRODUCT IN COMMERCE Approximately 3,019.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Model AED20, part number 972200E.
CODE Serial numbers 201887, 204213, 205309, 205857, 205869, 205870, 205871, 205872, 205873, 205874, 205875, 205876, 205877, 205878, 206073, 206075, 206076, 206077, 206078, 206079, 206080, 206081, 206094, 206096, 206097, 206098, 206101, 206111, 206112, 206113, 206114, 206115, 206116, 206117, 206118, 206119, 206120, 206122, 206123, 206124, 206125, 206126, 206127, 206128, 206129, 206130, 206131, 206132, 206133, 206136, 206137, 206138, 206139, 206140, 206141, 206142, 206143, 206144, 206145, 206146, 206147, 206149, 206150, 206151, 206152, 206153, 206154, 206159, 206160, 206162, 206163, 206164, 206165, 206167, 206168, 206169, 206170, 206171, 206172, 206173, 206174, 206175, 206176, 206177, 206178, 206179, 206180, 206181, 206182, 206183, 206184, 206185, 206186, 206187, 206188, 206189, 206190, 206191, 206192, 206193, 206194, 206195, 206196, 206197, 206198, 206199, 206200, 206201, 206202, 206203, 206204, 206205, 206206, 206207, 206208, 206209, 206210, 206212, 206213, 206214, 206215, 206216, 206217, 206218, 206219, 206220, 206221, 206222, 206223, 206224, 206225, 206226, 206227, 206228, 206229, 206230, 206231, 206232, 206233, 206234, 206235, 206236, 206237, 206238, 206239, 206240, 206241, 206242, 206243, 206244, 206245, 206246, 206247, 206248, 206249, 206250, 206251, 206252, 206253, 206254, 206255, 206256, 206257, 206258, 206259, 206260, 206261, 206262, 206264, 206265, 206266, 206267, 206268, 206269, 206270, 206271, 206272, 206273, 206274, 206275, 206276, 206277, 206278, 206279, 206280, 206281, 206282, 206284, 206285, 206286, 206287, 206289, 206290, 206291, 206292, 206293, 206294, 206295, 206296, 206297, 206298, 206299, 206300, 206301, 206302, 206303, 206304, 206305, 206306, 206307, 206308, 206309, 206310, 206311, 206312, 206313, 206314, 206315, 206316, 206317, 206318, 206319, 206320, 206321, 206322, 206323, 206324, 206326, 206328, 206329, 206331, 206332, 206333, 206334, 206335, 206336, 206337, 206338, 206339, 206340, 206342, 206343, 206344, 206345, 206346, 206347, 206348, 206349, 206350, 206351, 206352, 206353, 206354, 206355, 206356, 206357, 206358, 206359, 206360, 206361, 206362, 206363, 206364, 206365, 206366, 206367, 206368, 206369, 206370, 206372, 206373, 206374, 206375, 206376, 206377, 206378, 206379, 206380, 206381, 206382, 206383, 206384, 206385, 206386, 206387, 206388, 206390, 206391, 206392, 206394, 206395, 206396, 206397, 206398, 206399, 206400, 206401, 206402, 206403, 206404, 206405, 206406, 206407, 206408, 206409, 206410, 206411, 206412, 206414, 206415, 206416, 206417, 206418, 206419, 206420, 206421, 206422, 206423, 206424, 206425, 206426, 206427, 206428, 206429, 206430, 206431, 206432, 206433, 206434, 206435, 206436, 206438, 206439, 206441, 206442, 206443, 206444, 206445, 206446, 206447, 206448, 206449, 206450, 206451, 206452, 206453, 206454, 206455, 206456, 206457, 206458, 206459, 206460, 206461, 206462, 206463, 206464, 206465, 206466, 206467, 206468, 206469, 206470, 206471, 206472, 206473, 206474, 206475, 206477, 206478, 206479, 206480, 206481, 206482, 206483, 206484, 206485, 206486, 206487, 206488, 206489, 206490, 206491, 206492, 206493, 206494, 206495, 206496, 206497, 206498, 206499, 206500, 206501, 206503, 206504, 206505, 206506, 206507, 206508, 206509, 206510, 206511, 206512, 206513, 206514, 206515, 206516, 206517, 206518, 206519, 206520, 206521, 206522, 206523, 206524, 206525, 206526, 206527, 206528, 206529, 206530, 206531, 206532, 206533, 206534, 206535, 206536, 206537, 206538, 206539, 206540, 206541, 206542, 206543, 206544, 206545, 206546, 206547, 206548, 206549, 206550, 206551, 206552, 206553, 206554, 206555, 206556, 206557, 206558, 206559, 206560, 206561, 206562, 206563, 206564, 206565, 206566, 206567, 206568, 206569, 206570, 206571, 206572, 206573, 206574, 206576, 206577, 206578, 206579, 206580, 206581, 206582, 206583, 206584, 206585, 206586, 206587, 206588, 206589, 206590, 206591, 206592, 206593, 206594, 206595, 206597, 206598, 206599, 206600, 206601, 206602, 206603, 206604, 206605, 206606, 206607, 206608, 206609, 206610, 206611, 206612, 206613, 206614, 206615, 206616, 206618, 206619, 206620, 206621, 206622, 206623, 206624, 206625, 206626, 206627, 206628, 206629, 206630, 206632, 206633, 206634, 206635, 206636, 206637, 206638, 206639, 206640, 206641, 206642, 206643, 206644, 206645, 206646, 206647, 206648, 206649, 206650, 206651, 206652, 206653, 206654, 206655, 206656, 206657, 206658, 206659, 206660, 206661, 206662, 206663, 206664, 206665, 206666, 206667, 206668, 206669, 206670, 206671, 206672, 206673, 206674, 206675, 206676, 206677, 206678, 206679, 206680, 206681, 206682, 206683, 206684, 206685, 206686, 206687, 206688, 206689, 206690, 206691, 206693, 206694, 206695, 206696, 206697, 206698, 206699, 206700, 206701, 206702, 206703, 206704, 206705, 206706, 206707, 206708, 206709, 206710, 206711.
RECALLING FIRM/MANUFACTURER MRL, Inc., A Welch Allyn Company, Buffalo Grove, IL
REASON The Welch Allyn AED 20 product may display a "Defib Comm" error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropiate therapy.
VOLUME OF PRODUCT IN COMMERCE 597 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components specified by the customer and individualized for their bypass circuit set up requirements. Intersept Custom Tubing Pack, Sterile and nonpyrogenic Fluid Path: Do not use if package is opened or damaged. For Single Use Only. Label reads: Manufacturer: Medtronic, Inc. Minneapolis, MN. CODE Catalog/custom Pack Number 0A39R17 with Lot no.'s 0411002937 and 0412002577 Catalog/Customer Pack Number 0A52R12 with Lot no. 0411005077; Catalog/Customer Pack Number 0E35R1 with Lot no. 0501004491; Catalog/Customer Pack Number 0M97R17 with Lot no. 0411005084; Catalog/Customer Pack Number 0M97R18 with Lot no. 0501002954; Catalog/Customer Pack Number 0M98R18 with Lot no. 0411003731; Catalog/Customer Pack Number 0M99R17 with Lot no. 0411003732; Catalog/Customer Pack Number 0N41R7 with Lot no.'s 0411000788, 0411006283, 0412002182 and 0501001313; Catalog/Customer Pack Number 0N70R14 with Lot no.'s 0411003196 and 0411003196; Catalog/Customer Pack Number 0R26R1 with Lot no. 0410004599; Catalog/Customer Pack Number 0Y50R8 with Lot no. 0501001053; Catalog/Customer Pack Number 0Z30R6 with Lot no. 0411000770; Catalog/Customer Pack Number 0Z99R1 with Lot no. 0502003204; Catalog/Customer Pack Number 1845R29 with Lot no. 0412005193; Catalog/Customer Pack Number 1A46R5 with Lot no. 0501003689; Catalog/Customer Pack Number 1A63R6 with Lot no. 0412002081; Catalog/Customer Pack Number 1B23R2 with Lot no. 0412001125; Catalog/Customer Pack Number 1B23R4 with Lot no. 0502002363; Catalog/Customer Pack Number 1B31R2 with Lot no.'s 0411002428, 0411003734, 0411006211, 0501001326, 0501002968 and 0501004492; Catalog/Customer Pack Number 1B37R4 with Lot no. 0501001675; Catalog/Customer Pack Number 1C33R1 with Lot no. 0411003738; Catalog/Customer Pack Number 1C44R4 with Lot no.'s 0410005787, 0412000449 and 0501004469; Catalog/Customer Pack Number 1C87R3 with Lot no. 0411005042; Catalog/Customer Pack Number 1D80R7 with Lot no. 0411003404; Catalog/Customer Pack Number 1D80R8 with Lot no. 0502000042; Catalog/Customer Pack Number 1E87R1 with Lot no. 0411002441; Catalog/Customer Pack Number 1E87R2 with Lot no. 04120030957; Catalog/Customer Pack Number 1E99R4 with Lot no. 0501002058; Catalog/Customer Pack Number 1F03R1 with Lot no. 0412000472; Catalog/Customer Pack Number 1F04R2 with Lot no's. 0412003489 and 0501002849; Catalog/Customer Pack Number 1G06R11 with Lot no. 0412001595; Catalog/Customer Pack Number 1G37R3 with Lot no. 0411003209; Catalog/Customer Pack Number 1G69R7 with Lot no. 0412002553; Catalog/Customer Pack Number 1G75R1 with Lot no. 0412003470; Catalog/Customer Pack Number 1H24R6 with Lot no. 0412001207; Catalog/Customer Pack Number 1H50R5 with Lot no. 0411003411; Catalog/Customer Pack Number 1J01R with Lot no. 0501002510; Catalog/Customer Pack Number 1J29R1 with Lot no. 0501002848; Catalog/Customer Pack Number 1K09R3 with Lot no. 0412002172; Catalog/Customer Pack Number 1K72R4 with Lot no. 0502000853; Catalog/Customer Pack Number 1L77R7 with Lot no. 0411006056; Catalog/Customer Pack Number 1M68R2 with Lot no. 0412002559; Catalog/Customer Pack Number 1N25R5 with Lot no. 0502003198; Catalog/Customer Pack Number 1N77R6 with Lot no. 0501002933; Catalog/Customer Pack Number 1N93R1 with Lot no. 0502002615; Catalog/Customer Pack Number 1Q10R4 with Lot no. 0411006908; Catalog/Customer Pack Number 1Q28R1 with Lot no. 0412000476; Catalog/Customer Pack Number 1R13R2 with Lot no. 0411002155; Catalog/Customer Pack Number 1R14R2 with Lot no. 0501005938; Catalog/Customer Pack Number 1U84R3 with Lot no. 0411006923; Catalog/Customer Pack Number 2162R3 with Lot no.'s 0411005070 and 0412005207; Catalog/Customer Pack Number 2380R7 with Lot no. 0411006916; Catalog/Customer Pack Number 2567R34 with Lot no.'s 0412000978 and 0501003678; Catalog/Customer Pack Number 2841R32 with Lot no. 0411000393; Catalog/Customer Pack Number 2A96R with Lot no. 0411003443; Catalog/Customer Pack Number 2C88R2 with Lot no. 0412001122; Catalog/Customer Pack Number 2D86R8 with Lot no. 0411006913; Catalog/Customer Pack Number 2D93R6 with Lot no. 0411003730; Catalog/Customer Pack Number 2E74R9 with Lot no. 0411004495; Catalog/Customer Pack Number 2L74R4 with Lot no. 0411002893; Catalog/Customer Pack Number 2P77R3 with Lot no. 0411002443; Catalog/Customer Pack Number 2R17R1 with Lot no. 0412004981; Catalog/Customer Pack Number 2V38R2 with Lot no. 0411006212; Catalog/Customer Pack Number 2W79R1 with Lot no. 0411002930; Catalog/Customer Pack Number 2W98R6 with Lot no. 0412002558; Catalog/Customer Pack Number 2Y74R2 with Lot no. 0501000436; Catalog/Customer Pack Number 2Y78R5 with Lot no.'s 0412001590 and 0501002781; Catalog/Customer Pack Number 3D21R1 with Lot no. 0411006924; Catalog/Customer Pack Number 3F11R2 with Lot no. 0412005199; Catalog/Customer Pack Number 3F83R1 with Lot no.'s 0412002171, 0412003472 and 0412004460; Catalog/Customer Pack Number 3L07R2 with Lot no. 0501004498; Catalog/Customer Pack Number 3Q80R3 with Lot no. 0412003468; Catalog/Customer Pack Number 3R14R4 with Lot no. 0502001780; Catalog/Customer Pack Number 3S01R4 with Lot no. 0502002361; Catalog/Customer Pack Number 3S79R2 with Lot no. 0411006608; Catalog/Customer Pack Number 3V39R with Lot no. 0411006910; Catalog/Customer Pack Number 4B19R3 with Lot no. 0502001785; Catalog/Customer Pack Number 4B82R with Lot no. 0501005425; Catalog/Customer Pack Number 9015R8 with Lot no. 0411003414; Catalog/Customer Pack Number 9063R9 with Lot no. 0501002505; Catalog/Customer Pack Number 9251R16 with Lot no.''s 0411003749 and 0412004062; Catalog/Customer Pack Number CB0M50R2 with Lot no.'s 0411006331 0412000701 and 0412003740; Catalog/Customer Pack Number CB0R21R2 with Lot no. 0411005057; Catalog/Customer Pack Number CB0S15R7 with Lot no.'s 0411004246, 0412003181 and 0501004470; Catalog/Customer Pack Number CB1C78R11 with Lot no.'s 0411005055 and 0412001564; Catalog/Customer Pack Number CB2690-1 with Lot no. 0411002434; Catalog/Customer Pack Number CB2C36R10 with Lot no. 0412001209; Catalog/Customer Pack Number CB2E68R3 with Lot no.'S 0411006933 and 0412005212; Catalog/Customer Pack Number CB2H63R5 with Lot no. 0412003184; Catalog/Customer Pack Number CB2K05R4 with Lot no.'S 0411003199 and 0412001229; Catalog/Customer Pack Number CB2Z67R2 with Lot no. 0412005211; Catalog/Customer Pack Number CB3L15R3 with Lot no. 0411005056; Catalog/Customer Pack Number CB3Q10R1 with Lot no. 0501004457; Catalog/Customer Pack Number CB3T25R2 with Lot no. 0501005426; Catalog/Customer Pack Number CB3U51R2 with Lot no. 0411006084; Catalog/Customer Pack Number CB3U51R5 with Lot no.'s 0501000085 and 0501000443; Catalog/Customer Pack Number CB3W16R3 with Lot no. 0502001415; Catalog/Customer Pack Number CB3Z05R with Lot no.'s 0411006935 and 0502002616; Catalog/Customer Pack Number CB4B28R with Lot no. 0501002773; Catalog/Customer Pack Number HY2J04R2 with Lot no. 0412000923; Catalog/Customer Pack Number HY2U30R3 with Lot no. 0411001294 and 0501001294; Catalog/Customer Pack Number HY3E77R6 with Lot no.'s 0410008224, 0412001560 and 0501002937; Catalog/Customer Pack Number HY3Y36R with Lot no. 0501003677; Catalog/Customer Pack Number TL2K47R3 with Lot no.'s 0411003194 and 0412003178; Catalog/Customer Pack Number TL2M65R1 with Lot no. 0410003692; Catalog/Customer Pack Number TL2P93R1 with Lot no.'s 412001991, 0501002979 and 0502002686; Catalog/Customer Pack Number TL2P94R6 with Lot no. 0412000922; Catalog/Customer Pack Number TL2Q00R6 with Lot no. 0411003751; Catalog/Customer Pack Number TL2Q02R6 with Lot no. 0412002584; Catalog/Customer Pack Number TL2S57R3 with Lot no. 0411006070; Catalog/Customer Pack Number TL3B47R8 with Lot no.'s 0411004731 and 0412005219; Catalog/Customer Pack Number TL3C36R1 with Lot no. 0501001293; Catalog/Customer Pack Number TL3C66R4 with Lot no. 0412003164; Catalog/Customer Pack Number TL3F46R1 with Lot no. 0502000857; Catalog/Customer Pack Number TL3G03R1 with Lot no. 0411004739; Catalog/Customer Pack Number TL3G34R with Lot no.'s 0411004988 and 0411006937; Catalog/Customer Pack Number TL3H76R7 with Lot no.'s 0411004741 and 0501001692; Catalog/Customer Pack Number TL3P08R with Lot no.'s 0411003748 and 0412005195; Catalog/Customer Pack Number TL3R32R with Lot no. 0411006939; Catalog/Customer Pack Number TL3R59R4 with Lot no. 0411003763; Catalog/Customer Pack Number TL3Z67R2 with Lot no.'s 0412004544 and 0501000804; and Catalog/Customer Pack Number TL4A82R with Lot no. 0411006604. TOTAL SYSTEMS: Total System TS8184R9 with Lot no.'s 11323584, 11281448, 11262323, 11229369 and 11189019; Total System TS8161R6 with Lot no.'s 11301690, 11271898, 11190528 and 11376510; Total System TS8163R7 with Lot no.'s 11294151, 11278357, 11249648, 11235370, 11209905, 11172365, 11159434, 11127913 and 11092587 ; Total System TS9632R32 with Lot no.'s 11314733, 11264825 and 11199673; Total System TS9422R30 with lot no.'s 11085227, 11101188, 11022556, 11369433, 11208288 and 11151238A; Total System TS1265R6 with Lot no.'s 11344914, 11341867, 11216620 and 11213665; Total System TS1231R10 with Lot no.'s 11276692, 11036456 and 11007721; Total System TS8240R3 with Lot no.'s 11348660 and 11271850; Total System TS8258R1 with Lot no.'s 11361686 and 11343264; Total System TS8151R7 with Lot no.'s 11281057, 11259915, 11245459, 11236224, 11209834 and 11196880; Total System TS8009R7 with Lot no.'s 11432303, 11389716B, 11365733, 11365733B, 11353727, 11297859, 11277544A, 11388228, 11389716B, 11384983A, 11365733B and 11374909; Total System TS8101R5 with Lot no.'s 11355174, 11326135, 11280917, 11261447, 11246651, 11233518, 11219744, 11187093, 11154628, 11148913, 11146030 and 11025969; Total System TS8387R with lot no. 10935463; Total System TS 8363R with lot no.'s 11232452, 11209241, 11170011, 11134085, 11044590, 11280218, 11355877A, 11319313, 11362213, 11335475, 11322560, 11277524 and 11221479; Total System TS8275R2 with Lot No.'s 11143684, 11117484, 11113585 and 11078654; Total System TS8287R with Lot no. 11304060; Total System TS8299R with Lot no.'s 11237797 and 11207329; Total System TS8385R with lot no.'s 10890724 and 11157079A; Total System TS8329R3 With Lot no.'s 11319074, 11282455, 11269241, 11260213, 11237174, 11211041, 11355036 and 11326059; Total System TS8339R1 with Lot no.'s 11240930, 1161677 and 11364737; Total System TS8394R1 with Lot no. 11275457; Total System TS8329R3 with Lot no.'s 11454233, 11435228, 11404947 and 11392251; Total System TS8390R with Lot no. 11019052; and Total System TS 8367R1 with Lot no.'s 11247834, 11107184, 11063353, 11033869, 11355872, 11278049 and 11144479.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN
Manufacturer: Medtronic Mexico, S. De R.L. De C.V., Tijuana, Baja California, Mexico.
REASON Some warehouse inventory of Custom Pack product bags were found with ruptured seals. The seals were partially opened in the center of the bag's Tyvek edge. Since this bag is used to enclose and seal the custom pack assembly and had been sterilized, the ruptured seal breaches the sterility barrier for the package.
VOLUME OF PRODUCT IN COMMERCE 4,131 devices (3,373 within US).
DISTRIBUTION Nationwide and Internationally.

PRODUCT Nichols IRMA Intact PTH Assay, catalog No. 40-2171.
CODE Lots 40-504553/4 released March 4, 2005 and kit lots 40-501687/8 released March 18, 2005.
RECALLING FIRM/MANUFACTURER Nichols Institute Diagnostics, San Clemente, CA
REASON Firm noted a change in performance and therefore changed the labeled performance specifications in the Directional Insert portion of the labeling.
VOLUME OF PRODUCT IN COMMERCE Not divulged.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040. .
CODE Lots 62-402598 and 62-402622.
RECALLING FIRM Nichols Institute Diagnostics, San Clemente, CA
REASON Values do not agree with Directional Instructions (DI). Lot 62-402598's results were outside the DI claim for functional sensitivity, reproducibility, parallelism and two interfering substances. Lot 62-402622's results were outside the DI claim for functional sensitivity, reproducibility, recovery, parallelism and two interfering substances.
VOLUME OF PRODUCT IN COMMERCE 13,751.
DISTRIBUTION Nationwide and Internationally.

PRODUCT The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen catheter with an elastomeric balloon near its tip. This device is used with a 200 cm j-hook guide wire accessory device. Product Code EC1001.
CODE Lot Number, exp. date: MS020434, EXP APRIL-2005; MS0504003, EXP APRIL-2005; MS0504027, EXP MAY-2005; MS0604006, EXP MAY-2005; MS0604007, EXP MAY-2005; MS0704006, EXP JUNE-2005; MS0704015, EXP JUNE-2005; MS0804007, EXP AUGUST-2005; MS1004007, EXP OCTOBER-2005; MS1104021, EXP OCTOBER-2005; MS0105002, EXP JANUARY-2006; MS0105047, EXP FEBRUARY-2006; MS0205039, EXP FEBRUARY-2006; MS0205036, EXP MARCH-2006; MS0205041, EXP MARCH-2006; MS0205042, EXP MARCH-2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartport, Inc., Somerville, NJ
Manufacturer: MedSource Technologies-Laconia, Laconia, NH.
REASON Guidewire is protruding through the film portion of the packages which compromises the sterility of the device.
VOLUME OF PRODUCT IN COMMERCE 1,029 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) ENTrak Navigation and Visualization System.
b) ENTrak Plus Navigation and Visualization System.
c) InstaTrak 3500 Navigation and Visualization System.
d) InstaTrak 3500 Plus Navigation and Visualization System.
CODE Axcess System Kit P/N: 1005869-001.
RECALLING FIRM/MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, UT
REASON Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
VOLUME OF PRODUCT IN COMMERCE 15 KITS.
DISTRIBUTION VA, CT, KY, NJ, LA,PA, TN, OK, CA, and Germany.

PRODUCT Tube Stand for the Dynarad Phantom Mobile X-Ray System. Catalog #501031.
CODE All Phantom Model Tube Stands with squared corners on all four corners of the stand. Serial numbers 00743-0204, 00778-0204, 00997-0304, 01001-0304, 01103-0304, 01293-0304, 01371-0304, 01425-0404, 01452-0404, 01470-0404, 01475-0404, 01575-0404, 01592-0404, 01700-0404, 01704-0404, 01790-0404, 01841-0404, 01851-0404, 01898-0504, 02019-0504, 02023-0504, 02051-0504, 02096-0504, 02178-0504, 02188-0504, 02310-0604, 02357-0604, 02429-0604, 02517-0604, 02534-0604, 02584-0604, 02671-0604, 02752-0704, 02760-0704, 02776-0704, 02839-0704, 02891-0704, 02928-0704, 02938-0704, 02945-0704, 02959-0704, 02980-0704, 02991-0704, 03076-0704, 03084-0704, 03122-0704, 03375-0804, 03455-0804, 03476-0804, 03518-0804, 03534-0804, 03570-0904, 03579-0904, 03636-0904, 03700-0904, 03708-0904, 03722-0904, 03740-0904, 03952-0904, 04037-0904, 04134-1004, 04183-1004, 04347-1004, 04380-1004, 04407-1004, 04477-1004, 04481-1004, 04491-1004, 04524-1004, 04534-1004, 04592-1104, 04600-1104, 04605-1104, 04648-1104, 04694-1104, 04699-1104, 04703-1104, 0439-1104, 04783-1104, 04862-1104, 05190-1204, 05194-1204, 05198-1204, 05216-1204, 05364-1204, 05414-1204, 05418-1204, 05439-1204, 00283-0105, 00340-0105, 00481-0105, 00571-0205, 00575-0205, 00617-0205, 00649-0205, 00763-0205, 00841-0205, 00858-0205, 00891-0205, 00900-0205, 00913-0205.
RECALLING FIRM/MANUFACTURER Del Medical Systems Group, Franklin Park, IL
REASON The Phantom Portable X-Ray System Stand may have a suspect weld supporting the bracket holding the locking cylinder assembly. If the weld fails, the tubehead arm assembly could fall and contact the patient or operator.
VOLUME OF PRODUCT IN COMMERCE 31 tubestands.
DISTRIBUTION Nationwide, Mexico and Thailand.

PRODUCT KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak Direct View CR 500 systems. Screens are sold in the following sizes and Cat. No's: (1) Cat. #812-7334 - 15 x 30 cm; (2) Cat #825-9269 - 18 x 24 cm; (3) Cat #167-8663 - 24 x 30 cm; (4) Cat #810-7823 - 35 x 35 cm; (5) Cat #160-5906 - 35 x 43 cm. .
CODE Each screen has a 17-digit code. Product subject to recall includes ALL codes containing "CE" and "CR" and codes with "CO" with date code of "051" or lower. NOTE: The date codes are the 8th thru 10th digit and equal the julian date. The YEAR CODES are the 11th and 12th digit. The codes are located at the top edge of the CR screen. i.e. xxxxxxx051CO#xxxx.
FIRM/MANUFACTURER Eastman Kodak Co., Rochester, NY
REASON Screens may be affected with image artifacts.
VOLUME OF PRODUCT IN COMMERCE 6,900 screens.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Axiom Artis MP X-Ray System.
CODE Serial numbers 10, 1021, 1025, 1026, 1027, 1043, 1044, 1048, 1050, 1052, 1056, 1065, 1067, 1069, 1080, 1082, 1083, 1085, 1087, 1089, and 1097.
RECALLING FIRM Siemens Medical Solutions USA, Inc., Malvern, PA
REASON Potential problem with the fluoroscopy switch on the power grip.
VOLUME OF PRODUCT IN COMMERCE 21 units.
DISTRIBUTION Nationwide.

PRODUCT ECAT PET Scanners (mobile systems), Reveal XL (mobile systems), and Sceptre and Sceptre XL (mobile systems).
CODE Model Number: 3600079-00 Serial numbers: 0001013, 0001014 Model Number: 3600088-00 Serial numbers: 0001010, 0001016, 0001017, 0001019, 0001021, 0001023, 0001027, 0001029, 0001030, 0001031, 0001038, 0001041, 0001048, 0001051, 0001053, 0001054 Model Number: 3600097-00 Serial numbers: 0101004, 0101019, 0101025, 0101033, 0201041, 0201049, 0201053, 0201063 Model Number: 3600211-00 Serial numbers: 0101007, 0101016, 0101018, 0201023, 0201048, 0201050, 0201058, 0201064, 0201072, 0301082, Marketed under Siemens Model Number: 3600211-00 0101002, 0101004, 0101015, 0101014, 0101020, 0101021, 0201029, 0201028, 0201035, 0201062, 0201059, 0201063, 0201070, 0301110 Model Number: 3600079-00 Serial numbers: 0001010, 0001011, 0001018 Model Number: 3600085-00 Serial numbers: 0001001, 0001002 Model Number: 3600088-00 Serial numbers: 0001003, 0001006, 0001020, 0001035, 0001036, 0001043, 0001045, 0001044, 0001056, 0001062 Model Number: 3600097-00 Serial numbers: 0101016, 0101018, 0101030, 0201036, 0201040, 0201060 Model Number: 3600211-00 Serial numbers: 0201033, 0201034, 0201067, 0301108 Model Number: 3600099-00 Serial numbers: 0301024 Model Number: 3600088-00 Serial numbers: 001058 Model Number: 3600097-00 Serial numbers: 0101034, 0201038, 0201061.
FIRM/MANUFACTURER: CTI PET Systems Inc., Knoxville, TN
REASON Failure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during transit.
VOLUME OF PRODUCT IN COMMERCE 80 units.
DISTRIBUTION Nationwide, Canada, the Netherlands, Ireland and Denmark.

PRODUCT Moi-Stir oral swabsticks, an aid to mouth care and oral hygiene, Contents: 3 fibre-tipped swabsticks premoistened with Moi-Stir mouth moistening solution and saliva supplement; Product No's. 55299-703-03 and 55299-703-25. Swabs are sold only in case quantities of 25 foil packs to the carton and 100 fail packs to the case.
CODE Lots A2, 1193, 1209, 1233, 1260 and 1725.
RECALLING FIRM/MANUFACTURER Kingswood Laboratories, Inc., Indianapolis, IN
REASON Contaminated with Aspergillus and Penicillum molds.
VOLUME OF PRODUCT IN COMMERCE 302,600 swabs.
DISTRIBUTION Nationwide.

PRODUCT
a) Dunlee DA 200 & MX 200 CT X-Ray Tube Housing Assembly (989600087501); replacement x-ray tube housing assemblies; Model DA 200 and MX200, Part number 875-01;
b) Dunlee DA 200 PRO & MX 200 PRO CT X-Ray Tube Housing Assembly (989600088401); replacement x-ray tube housing assemblies; Model DA 200 PRO and MX200 PRO, part number 875-01.
c) Dunlee DA 200 Ultra & MX 200 Ultra CT X-Ray Tube Housing Assembly (989600088701); replacement x-ray tube housing assemblies; Model DA 200 Ultra and MX200 Ultra, Part number 875-01.
CODE
a) Serial (anode) numbers 13426, 13428, 13437, 13449, 15714, 16539, 16941, 16942, 16951, 16962, 16963, 17536, 17539, 17541, 17543, 17547, 18727, 18728, 18729, 18731, 18732, 18733, 18736, 18743, 18745, 18747, 18749, 18753, 18755, 18999, 20206, 20208, 20211, 20216, 20219, 20220, 20222, 20225, 21800, 21803, 21806, 21809, 21810, 21816, 21818, 21819, 21820, 21823, 21824, 21825, 21827, 21829, 21843, 21849, 21853, 23113, 23122, 23132, 23140, 23143, 23144, 23516, 23518, 23522, 23524, 23532, 23534, 23554, 23888;
b) Serial (anode) numbers 17549, 18997, 21821, 23112;
c) Serial (anode) numbers 18986, 18987, 18988, 18996, 19000, 19004, 21799, 21801, 21841, 21844, 23107, 23116, 23117, 23121, 23124, 23125, 23126, 23137, 23139, 23525, 23529, 23536, 23537, 23538, 23541, 23542, 23544, 23545, 23548, 23550, 23552, 23883, 23884, 23894, 23895, 23906, 23908.
RECALLING FIRM/MANUFACTURER Dunlee, Aurora, IL
REASON The X-ray tube housing assembly may have been mounted with the incorrect sized bolts.
VOLUME OF PRODUCT IN COMMERCE 110 units.
DISTRIBUTION Nationwide and Taiwan, Germany and Mexico.

PRODUCT Continuum MR Compatible Infusion Pump. Pump Model #3009135.
CODE Serial numbers 1000 through 300017.
RECALLING FIRM/MANUFACTURER Medrad, Inc., Indianola, PA
REASON Customer complaint that a continuum infusion pump was attracted to an MR scanner due to customer not completely engaging the pump into the bracket.
VOLUME OF PRODUCT IN COMMERCE 461 units.
DISTRIBUTION CA, DC, MD, NJ, SC, WA, WV, and Internationally.

PRODUCT The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65709-HFWC, and PT-12709-WC) consists of a catheter with an expandable fragmentation basket attached to a through lumen torque cable and an outer catheter sheath. The catheter is used in conjunction with a low-speed, battery operated rotator unit to treat thrombosed hemodialysis grafts and AV fistulas. The macerating mechanism is done by 9 mm basket (made up of four stranded stainless steel wires) that rotates at 3000 rpm when rotator is activated. The current device is 7 Fr in size and comes in two lengths -- 65 cm and 120 cm. This device is used by inserting the catheter into the occluded graft or fistula via introducer sheath and then activating the rotator unit.
CODE All units with Lot Numbers beginning with: MF311; MF312; MF401; MF402; MF403; MF404; MF405; MF406; MF407; MF408; MF409; MF410; MF411; MF412; MF501.
RECALLING FIRM/MANUFACTURER Arrow International, Inc., Reading, PA
REASON The orange Pebax lumen located within the catheter basket may separate from the catheter basket sleeve permitting the lumen to become dislodged during use.
VOLUME OF PRODUCT IN COMMERCE 2,418 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin Anafluor Indirect Fluorescent Antibody Test.
CODE All versions of software.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diasorin Inc., Stillwater, MN
Manufacturer: Polymedco, Inc., Cortlandt Manor, NY.
REASON A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered or changed (including values changed to unacceptable values) after the initial curve has been generated, if the "refresh button" has not been pressed. The graph may appear valid; however erroneous results may occur.
VOLUME OF PRODUCT IN COMMERCE 68 (27-2.7; 14-2.8 and 27-2.8.1 Software Version).
DISTRIBUTION Nationwide.

PRODUCT
a) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654225.
b) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654335.
c) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925474325.
d) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925554325.
e) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925574325.
f) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654220.
g) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654325.
h) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674320.
i) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674335.
j) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925754335.
k) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925774325.
l) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 92E654325.
CODE
a) Serial no. 706692007;
b) Serial no. 706741003;
c) Serial no. 706573001, 706573002, 706590000 and 706590001;
d) Serial no. 706710004, 706710005, 706710006, 706710007, 706710008 and 706710009;
e) Serial no. 706503016, 706503017, 706503018, 706503019, 706503020, 706503021, 706503022, 706503023, 706503024, 706503025, 706640011, 706640012, 706640013, 706640014, 706640015, 706640016, 706640017, 706640018, 706640019,
706640020, 706640021, 706640022, 706640023, 706640024, 706640025, 706640026, 706640027, 706640028, 706640029 and 706740000;
f) Serial no. 706522000, 706522001, 706522002, 706522003, 706522004, 706522005, 706522006, 706522007, 706522008, 706522009, 706522013, 706522024, 706522026, 706522027 and 706522028;
g) Serial no. 706330001, 706330002, 706330003, 706330004, 706330005 and 706431007;
h) Serial no. 706607001;
i) Serial no. 706684000 and 706884001;
j) Serial no. 706331000, 706331001, 706331002, 706331003, 706331004, 706331005, 706331006, 706331007, 706331008, 706331009, 706331010, 706331011, 706331012, 706331013 and 706331014;
k) Serial no. 706580000, 706580002, 706580003, 706580004, 706592000, 706592007, 706592010 and 706640010;
l) Serial no. 706460000, 706460001, 706601000, 706601001, 706601002, 706601003, 706601004, 706601005, 706601006, 706601007, 706601008, 706601009 and 706601010.
RECALLING FIRM/MANUFACTURER Smiths Medical PM, Inc, Waukesha, WI
REASON Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). The % CO values displayed will be lower than the actual CO2 value.
VOLUME OF PRODUCT IN COMMERCE 102 monitors (2 domestic and 100 international).
DISTRIBUTION CA, NY and Internationally.

PRODUCT
a) Centurion brand CirClamp with 1.3 cm bell, sterile, single use: product 330.
b) Centurion brand CirClamp with1.1 cm bell, sterile, single use; product 310. 5.
CODE
a) Lots 11224 and 06284;
b) Lot 11224.
RECALLING FIRM/MANUFACTURER Tri-State Hospital Supply Corp, Howell, MI
REASON Lot 11224 of product 330 may contain a 1.1 cm clamp and bell and neither lot is labeled as reprocessed, when they have been reprocessed.
VOLUME OF PRODUCT IN COMMERCE 5,650.
DISTRIBUTION Nationwide.

WEEK ENDING MAY 28

PRODUCT
a) LifeScan brand OneTouch Ultra Blood Glucose Meter.
b) LifeScan brand OneTouch FastTake Blood Glucose Meter.
c) LifeScan brand InDuo Blood Glucose Meter.
CODE ALL CODES: All lot numbers and serial numbers.
RECALLING FIRM/MANUFACTURER Lifescan Inc, Milpitas, CA
REASON User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
VOLUME OF PRODUCT IN COMMERCE Approximately 6.0M units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Simplastin HTFÆ Reagents, 20ml H2O, (and 6 ml H2O). Product numbers 259846, 259847.
CODE Lot numbers: 161849, 161800 and 161798. Recall Expanded (03/23/2005) to include these additional lot numbers: 161655, 161710, 161741, 161738, 161742, 1621739, 161743, 161740, 161764, 161763, 161797 and 161799.
RECALLING FIRM/MANUFACTURER Biomerieux, Inc, Durham, NC
REASON The ISI labeling for SimplastinÆ HTF on the Coag-a-MateÆ MAX and Thrombolyzer instrument platforms is not correct. The Simplastin HTF ISI assignment was mis-assigned and the published values are higher than expected for the listed instrument platforms.
VOLUME OF PRODUCT IN COMMERCE 19,748 kits.
DISTRIBUTION Nationwide, Canada, Columbia, India, Philippines, Spain and Thailand.

PRODUCT Cool/Heat Versatility Main Controller Unit with 7-pin port only (for use with Thermal Resistive Type mattress).
CODE Unit Serial Numbers 1020V0503E00174 1020V0304E00058 1020V0403E00145 1020V0203E00102 1020V0503E00088 1020V0403E00153.
RECALLING FIRM/MANUFACTURER AMF Support Surfaces, Inc., Corona, CA
REASON Operator misconnected device power cords causing failure of the device.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION IN, MD, and ND.

PRODUCT Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutions with a needleless luer syringe;
CODE Product code 2C6255, lot R04J12126; Product code 2C8428, lot R04J11318; Product code 2C8515, lot R04J12043; Product code 2C8519, lots R04J12076, R04J12159; Product code 2C8537, lots R04J11128, R04J11201, R04J12027, R04J12084, R04J12183, R04J13033, R04J13116, R04J13173, R04J14031, R04J14098, R04J14130, R04J14155, R04J15061; Product code 2C8546, lot R04J11177; Product code 2C8571, lot R04J14205; Product code 2C8606, lot R04J13025; Product code 2C8612, lot R04J12019; Product code 2C8632, lot R04J12258; Product code 2C8634, lot R04J13090; Product code 2C8819, lots UR241323, UR242560, UR242669; Product code 2C8864, lot UR240697; Product code 2C8865, lots UR241638, UR241786, UR244012; Product code A2C9801, lots UR244020, UR245647; Product code 2H8401, lot R04J12068; Product code 2H8519, lots R04J15053, R04J16010; Product code 2N8371, lot UR245027; Product code 2N8373, lot UR243501; Product code 2N8374, lots UR229138, UR229526, UR230193, UR230193X, UR230433, UR230458, UR240747, UR241059, UR241356, UR241505, UR242065, UR246033; Product code 2N8378, lots UR229344, UR229781, UR230060, UR241133, UR241661, UR242107, UR242131, UR242362, UR242644, UR244632; Product code 2N8399, lots UR230128, UR230573, UR231027, UR231704, UR239301, UR239889, UR240200, UR240945, UR241265, UR242081, UR242230, UR243576.
RECALLING FIRM
Recalling Firm: Baxter Healthcare, Corp, Round Lake, IL
Manufacturer: Baxter Healthcare, Corp. of Puerto Rico, Aibonito, PR. .
REASON Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve.
VOLUME OF PRODUCT IN COMMERCE 1,171,116 sets.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Altaire, Magnetic Resonance Imaging Device.
CODE Serial numbers: L001 to L191.
RECALLING FIRM/MANUFACTURER Hitachi Medical Systems America, Inc., Twinsburg, OH
REASON The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the compressor.
VOLUME OF PRODUCT IN COMMERCE 189 devices.
DISTRIBUTION Nationwide.

PRODUCT Fresh Look * Radianceô * Moonlight, (phemfilcon) Contact Lenses * -2.75 median, Median Dia:14.5 * Rx only * The product has been distributed in twin packs containing six pairs of lenses.
CODE Lot #124637.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ciba Vision Corp., Duluth, GA
Manufacturer: Ciba Vision Corp., Des Plaines, IL.
REASON The actual power of the lenses may be different from what is indicated on the package labeling.
VOLUME OF PRODUCT IN COMMERCE 2,250 units.
DISTRIBUTION Nationwide and Europe.

PRODUCT Philips Medical HeartStart MRx Monitor/Defibrillator, Model: M3535A, M3536A.
CODE Software Versions A.03.00 or lower and B.04.00 and lower.
RECALLING FIRM/MANUFACTURER Philips Medical Systems, Andover, MA,
REASON The device may disarm and not deliver shock when performing a Synchronized Cardioversion.
VOLUME OF PRODUCT IN COMMERCE 5,125 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models: NT186901(D); NT187901(D); NT186902(D); NT187902(D); NT356901(D); NT357901(D);NT356902; NT357902(D).
CODE All codes.
FIRM/MANUFACTURER Edwards Lifesciences Llc, Irvine, CA
REASON Potential for deployment difficulties.
VOLUME OF PRODUCT IN COMMERCE 537 units.
DISTRIBUTION Nationwide and Europe.