OCTOBER 2004

WEEK ENDING OCTOBER 2

PRODUCT 8870 software application card Version AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N'Vision Clinician Program.
CODE Software Version AAA 02, BBB 04, BBC 02, and BBD 01.
RECALLING FIRM/MANUFACTURER Medtronic Inc, Neurological & Spinal Division, Columbia Heights, MN.
REASON Users may mistakenly enter a periodic bolus interval into the minutes field, rather than the hours field, resulting in drug overdoses. This issue is limited to programming the SynchroMed and SynchroMed EL pumps.
VOLUME OF PRODUCT IN COMMERCE 4,466 cards.
DISTRIBUTION Nationwide and Internationally.

PRODUCT The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. This is a prescription medical device intended for use by personnel under the direction of a physician. The ventilator is suitable for use in institutional, home and transport settings.
CODE Ventilators manufactured prior to September 2003. Affected LTV Model/ Serial's: LTV 1000- S# A06500, LTV 950- S# C07000, LTV 900- S# B03500, LTV 800- S# D01400.
RECALLING FIRM/MANUFACTURER Pulmonetic Systems, Inc, Minneapolis, MN
REASON LTV Series of Ventilators (Models 1000, 950, 900 and 800). The ventilator has not consistently switched to internal battery operation when the external DC power source has become inadequate to supply stable power, resulting in loss of ventilation to the patient.
VOLUME OF PRODUCT IN COMMERCE 10,299 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) ACOM.M angiographic x-ray system. Model number 4371741.
b) ACOM.M angiographic x-ray system. Model number 5215707.
CODE
a) Serial numbers: 1024 through 1639;
b) Serial numbers 1087, 1088,1089,1093, 1094, 1493, 1174, 1176, and 1212.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA.
REASON Possible problem reviewing images on the ACOM.M.
VOLUME OF PRODUCT IN COMMERCE 237 units.
DISTRIBUTION Nationwide.

PRODUCT Hill-Rom brand VersaCare Bed; Model P3200.
CODE All units.
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN.
REASON Pivot bolts on the sleep deck may become loose and fall out, allowing the head section to shift or to drop to one side, and a grounding warning label is missing.
VOLUME OF PRODUCT IN COMMERCE 5,048 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
CODE Serial Numbers: MC01475-D3; MC02325-K3; MC01476-D3; MC02120-I3; MC02017-I3; MC02004-I3; MC02011-I3; MC02018-I3; MC02047-I3; MC02039-I3; MC02196-I3; MC02279-K3; MC02295-K3; MC02298-K3; MC01478-D3; MC01491-D3; MC01496-D3; MC01865-G3; MC01455-D3; MC02281-K3; MC02237-I3; MC05179-C4; MC05180-C4; MC05191-C4; MC05194-C4; MC05206-C4; MC05218-C4; MC05223-C4; MC01497-D3; MC01452-D3; MC01473-D3; MC01490-D3; MC01493-D3; MC01861-G3; MC02354-K3; MC02293-K3; MC02303-K3; MC02316-K3; MC02134-I3; MC02138-I3; MC02148-I3; MC02321-K3; MC02292-K3; MC01487-D3; MC02285-K3; MC02309-K3; MC02313-K3; MC05082-C4; MC05107-C4; MC02306-K3; MC01862-G3; MC01918-H3; MC01479-D3; MC05183-C4; MC05189-C4; MC01474-D3; MC01477-D3; MC01450-D3; MC05072-C4; MC05075-C4; MC05083-C4; MC05089-C4; MC05090-C4; MC05105-C4; MC05178-C4; MC05195-C4; MC05209-C4; MC05210-C4; MC05212-C4; MC05213-C4; MC05214-C4; MC05215-C4; MC05217-C4; MC05224-C4; MC01448-D3; MC01449-D3; MC01464-D3; MC01481-D3; MC01495-D3; MC01859-G3; MC01867-G3; MC01890-H3; MC02348-K3; MC02359-K3; MC02363-K3; MC01453-D3; MC01860-G3; MC02199-I3; MC01460-D3; MC01806-G3; MC01954-H3; MC02135-I3; MC02136-I3; MC02146-I3; MC02168-I3; MC02171-I3; MC02278-K3; MC02280-K3; MC05172-C4; MC05173-C4; MC05174-C4; MC05181-C4; MC05184-C4; MC05188-C4; MC05190-C4; MC05201-C4; MC05203-C4; MC05208-C4; MC05219-C4; MC05222-C4; MC05225-C4; MC05227-C4; MC02002-I3; MC02005-I3; MC02006-I3; MC02008-I3; MC02020-I3; MC02023-I3; MC02025-I3; MC02027-I3; MC02030-I3; MC02034-I3; MC02043-I3; MC02044-I3; MC02048-I3; MC02052-I3; MC05182-C4; MC05185-C4; MC05192-C4; MC05199-C4; MC01869-G3; MC02326-K3; MC02344-K3; MC02357-K3; MC02365-K3; MC01866-G3; MC01868-G3; MC01929-H3; MC01949-H3; MC02187-I3; MC02277-K3; MC01482-D3; MC01488-D3; MC02177-I3; MC02290-K3; MC02317-K3.
RECALLING FIRM/MANUFACTURER Datascope Corp., Mahwah, NJ.
REASON The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex.
VOLUME OF PRODUCT IN COMMERCE 146 units.
DISTRIBUTION Nationwide.

PRODUCT CryoValve, Conduit and Pulmonary Valve and Conduit. Donor #66949. Model #SGPV00.
CODE Serial #7988716.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA.
REASON CryoLife received information regarding a positive culture for Group A Streptococcus infection in a recipient of tissue procured from the attached donor.
VOLUME OF PRODUCT IN COMMERCE 1 tissue.
DISTRIBUTION NM.

PRODUCT
a) Gluteraldehyde Concentration Indicators "Browne GA Indicator for CIDEX PLUS Products.
b) Gluteraldehyde Concentration Indicators "Browne GA Indicator for CIDEX Products.
c) Orthophthaladehyde Concentration Indicator Browne CIDEX OPA Indicator.
CODE
a) CIDEX PLUS code 2924 lots: 9467, 9514, 9517, 9533 CIDEX PLUS code 2926, lots: 9504, 9518, 9534, 9624, 9655;
b) CIDEX Activated code 2927, lots: 9520, 9656, 9695, 9804, 9896, 10001 CIDEX Activated Code 2920, lots: 9447, 9522,
9621, 9622, 9661, 9662, 96666, 9764, 9897;
c) CIDEX OPA code 20392, lots: 9272, 9273, 9433, 9434, 9436, 9461, 9512, 9513, 9537, 9538, 9578, 9593, 9664, 9699, 9743, 9744, 9745, 9746, 9814, 9815, 9816, 9854, 9935, 9984, 9985, 10019, 10028, 10036, 10037, 8101, 8144, 8218, 8233, 8321, 8482, 8483, 8510, 8511, 8512, 8513, 8514, 8618, 8630, 8631, 8632, 8636, 8637, 8638, 8792, 8793, 8794, 8795, 8796, 8797, 8798, 8978, 8980, 8981, 9130, 9131, 9133, 9270, 9271, 9272 CIDEX OPA code 20393, lots: 8079, 8102, 8219, 8223, 8421, 8456, 8515, 8550, 8633, 8639, 8970, 8982, 9075, 9260, 9274, 9275, 9536, 9564, 9663, 9796, 9907, 9908, 10000.
RECALLING FIRM/MANUFACTURER Advanced Sterilization Products, Irvine, CA.,
REASON Performance failure complaints, moisture ingress into the bottles was causing failure or variability in results.
VOLUME OF PRODUCT IN COMMERCE 122,914 cases.
DISTRIBUTION Nationwide and Internationally

.Pulmonetic Systems LTV Series of Ventilators

Pulmonetic Systems, Inc. notified healthcare professionals of a recall of the LTV series of ventilators, models 1000, 950, 900 and 800, designed to automatically switch to internal battery operation, allowing uninterrupted ventilation, when an external power source is removed or is no longer adequate to power the ventilator. The ventilators malfunction when switching to the internal battery, causing failure of the ventilator to breathe for the patient.

WEEK ENDING OCTOBER 9

PRODUCT Alveolus Tracheobronchial Stent Technology System (TB-STS).
CODE Size 12x40, Part #90129-20, Lot #AC0406; Size 14x40, Part #90129-21, Lot #AC0409; Size 16x40, Part #90129-22, Lot #AA0411; Size 16x60, Part #90129-23, Lot #A0413; Size 12x20, Part #90129-24, Lot #AA0404; Size 14x40, Part #90129-25, Lot 3AA0409; Size 14x40, Part #90129-26, Lot #AC0409; Size 16x60, Part #90129-27, Lot #AA0413.
RECALLING FIRM/MANUFACTURER Alveolus, Inc., Charlotte, NC.
REASON The tracheal stent may collapse resulting in blockage of the air passage because the stents were not properly coated with the polyurethane material to the very end of the stent.
VOLUME OF PRODUCT IN COMMERCE 47 units.
DISTRIBUTION FL, SC, and TX.

PRODUCT NT Intera Magnetic Resonance Image System.
CODE Part #s 9896 030 09981, 9896 030 10251 Site #s 504531, 104343, 59488, 41391, 37996, 37979, 85119, 26269, 59435, X1281, 504409, 102353, 13606, 103166, 37929, 104392, 103149, 84418, 6947, 63046, 86293, 102978, 103904, 105315, 504866, X0038, 103582, 100745, 101946, 103333, 504412, 13056, 100786, 59428, 103818, 105314, 50430, 104808, 85139, 45016, X0716, X0942, X1272, X1086, X0214, 103324, 101420, 103579, 103847, 6808, 104467, 38652, 103347, 14117, 86335, 68196, 104032, 103417, 103243, 103207, 104102, 52408, 6841, 47029, 41346, 45065, X0164, X1082, 104912, X0083, 104054, 83325, 103911, 101477, 250156, 25958, 104193, 102547, 85172, 104897, 104070, 506190, 103946, 504608, 104340, 100462, 505007, 101595, 104095, 13932, 87527, 38966, 87604, 50336, 86085, 103291, 103592, 103098, 38257, 104532, 101162, 504897, 87018, 104336, X1693, 59637, 103143, 102933, 505021, 103631, 103552, 82678, X1635, X0162, 14065, 103530, 505568, 500034, 250498, 103099, 38438, 76359, 104138, 101561, 101560, 47043, 17394, 105271, X1215, 13057, 250475, 102569, 103770, 86313, X1179, X1523, 504632, 504527, X1412, 104942, 38317, 103101, 26119, 103509, 103544, 85433, 103547, 250122, 102896, 85158, 41342, 86012, 103907, 103909, 101408, 38420.
RECALLING FIRM/MANUFACTURER Philips Medical Systems Sales & Service Region No. America, Bothell, WA.
REASON Potential for patient burn.
VOLUME OF PRODUCT IN COMMERCE 156 units.
DISTRIBUTION Nationwide.

PRODUCT Medtronic FLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036.
CODE Lot numbers 2003080199, 2003090147, 2003100101, 2004010371, and 2004030070.
RECALLING FIRM/MANUFACTURER Medtronic, Inc., Minneapolis, MN.
REASON Spiral tip from DLP VAD cannula may be loose and potentially detach during use.
VOLUME OF PRODUCT IN COMMERCE 753 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Impervious Stockinette, Large, 12” X 48” or 12” X 54”, Ref #9806-54, #9816-54, and #9978-12; X-Large, 16” X 48”, Ref #9978-16.

b) Stockinette, Single Ply Econo Weave, 8 X 72", Ref #9999-72.

c) Stockinette, Single Ply, Standard Weave, 8 X 72” and 10 X 48”, Ref #9508-72, #9510-48, #9510-48, #9510-60.

d) Stockinette, Double Ply, Standard Weave, 6 X 60", 6 X 72", 8 X 48", 8 X 60", 8 X 72", 10 X 48".

e) Stockinette, Double Ply, Econo Weave, 6 X 54", 6 X 60", 6 X 72", 8 X 48", 8 X 72", Ref #9984-54, #9984-54, #9985-60, #9986-72, #9987-48, #9988-60, #9988-72.

f) Stockinette, Double Ply, Econo Weave, EZ Roll, 6 X 60”, 8 X 60”, Ref#9991-60, #9993-60.
CODE
a) Lot # 1007298 1007335 1007360 1030228 1030244 1045526 1049113 1081519 1107441 1141972 1161316 1161332 1200979 1225252 1306538 1310369 1315021 1330597 1330600 1342811 1375681 1375808 1375816 1490540 1504008 1504032 1521713 1543630 1571438 1650988 1736028 1759511 1802072 1911543 1911615 2076658 2076738 2137810 2137828 2138062 2187067 2228121 2376204 2701345 765821 765855 804316 805431 805440 825580 825598 825635 825643 850507 900691 932991 933071 933097 933118 933151 950663 950680 950743 974585 974593 974665

b) Lot: 1503929

c) Lots: 1030279 1600315 929506 929514

d) Lot: 1007212 1030172 1030181 1142043 1225324 1225332 1225341 1225359 1306298 1330669 1330677 1341190 1375832 1375841 1375867 1375875 1407072 1431304 1521772 1543672 1543681 1627016 1634152 1678542 1678606 1736079 1736087 1736095 1736108 1736116 1800384 1800608 1876426 1911375 1911421 2055689 2075217 2136454 2136471 2268684 2375877 728683 783421 805360 805378 805482 825555 900762 900797 900800 974681 974729

e) Lots: 9984-54 9985-60 9991-60 9986-72 9987-48 9988-72

f) Lot: 932924 1330482 1407048.
RECALLING FIRM/MANUFACTURER Deroyal Surgical-Rose Hill, Rose Hill, VA.
REASON Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
VOLUME OF PRODUCT IN COMMERCE 3,098 cases.
DISTRIBUTION Nationwide, Ireland, Peru and Israel.

PRODUCT Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18-30, 4 x 500 tests.
CODE List 7C18-20, lots 10014M200, 08672M200, 07780M300 and 17048M100; list 7C18-25, lots 08672M201, 10014M201, 15692M100 and 17048M101; list 7C18-30, lots 09140M300, 09238M200, 08458M200, 02348M300, 10015M200 and 13251M100. list 7C18-20, lots 10014M200, 08672M200, 07780M300 and 17048M100; list 7C18-25, lots 08672M201, 10014M201, 15692M100 and 17048M101; list 7C18-30, lots 09140M300, 09238M200, 08458M200, 02348M300, 10015M200 and 13251M100.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL.
REASON There is a potential for significant differences in quantitative results for certain specimens when using the affected reagent lots.
VOLUME OF PRODUCT IN COMMERCE 6,691 kits.
DISTRIBUTION Canada, Japan, Australia, New Zealand, Germany and England.

PRODUCT Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.
CODE Lot #244468.
RECALLING FIRM/MANUFACTURER PerkinElmer LAS Inc., Norton, OH.
REASON The test kits are producing lower values than expected which may result in an increased number of false positive results increasing the risk of missing a baby with galactosemia.

VOLUME OF PRODUCT IN COMMERCE 49 kits.
DISTRIBUTION IN, MO, TX, WI, and MN.

PRODUCT Crosseal, fibrin sealant (human), One Applicator, Two Vial cups, Sterile, Disposable, Single Use, Rx Only.
CODE Lot 0404 exp. Oct. 2008; Lot 0417 exp. Jan. 2009; Lot 0419 exp. Jan. 2009.
RECALLING FIRM/MANUFACTURER Omrix Biopharmaceuticals, Ltd., Plasma Fract. Inst., Magen David Adom Blood Services Ctr., Ramat Gan, Israel.
REASON 5 mL Crosseal fibrin sealant (human) is difficult to expel from the device resulting in product leakage from the vial insertion port.
VOLUME OF PRODUCT IN COMMERCE 4,277 units.
DISTRIBUTION Nationwide.

WEEK ENDING OCTOBER 16

PRODUCT Aquasorb Æ Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part ***Sterile***.
CODE Lot 360025.
RECALLING FIRM/MANUFACTURER DeRoyal Wound Care, Rose Hill, VA.
REASON Wound dressing failed to meet sterility specifications.
VOLUME OF PRODUCT IN COMMERCE 4 cases.
DISTRIBUTION CA, OH and PA.

PRODUCT
a) Automated Differential Cell Counter.
b) Automated Differential Cell Counter.
CODE
a) Part Numbers: Pentra 80 P8000000NUA10;
b) Part Numbers: Pentra 80XL P80XL000NUA10.
RECALLING FIRM/MANUFACTURER ABX Diagnostics, Inc., Irvine, CA.
REASON Device can generate overestimated platelet results.
VOLUME OF PRODUCT IN COMMERCE 94 units.
DISTRIBUTION Nationwide.

PRODUCT Ameriwater Portable RO+, model numbers MR01 and MR02. The device is reverse osmosis system for dialysis.
CODE Serial Numbers effected: 21013, 21014, 21026, 21031, 21042, 21052, 21053, 21071, 21072, 21073, 21079, 21080, 21090, 21091, 21092, 21100, 21101, 21110, 21111, 21121, 21122, 21125, 21127, 21193, 21194, 21200, 21201, 21203, 21204, 21205, 21208, 21210, 21215, 21222, 21223, 21236, 21237, 21240, 21258, 21259, 21263, 21270, 21328, 21333, 21336, 21338, 21352, 21371, 21379, 21384, 21387, 21388, 21015, 21016, 21017, 21021, 21023, 21024, 21032, 21033, 21034, 21035, 21036, 21043, 21049, 21050, 21051, 21054, 21066, 21089, 21093, 21094, 21095, 21097, 21098, 21108, 21109, 21123, 21126, 21128, 21142, 21143, 21156, 21157, 21160, 21162, 21163, 21164, 21165, 21166, 21167, 21168, 21169, 21176, 21178, 21179, 21180, 21183, 21185, 21186, 21191, 21192, 21212, 21216, 21217, 21224, 21225, 21228, 21229, 21244, 21249, 21260, 21268, 21269, 21271, 21272, 21274, 21275, 21276, 21282, 21283, 21298, 21299, 21300, 21302, 21307, 21311, 21316, 21329, 21332, 21339, 21342, 21343, and 21346.
RECALLING FIRM/MANUFACTURER Ameriwater Inc., Dayton, OH.
REASON The device has a potential risk of failure caused by faulty wiring within the electrical component. The wires can overheat and eventually break in two.
VOLUME OF PRODUCT IN COMMERCE 148 units.
DISTRIBUTION Nationwide.

PRODUCT AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21.
CODE Lot #: 18357Q100, 18357Q101 (France), 18357Q102, 18357Q103 and 18357104(France). Exp. date 11/11/04.
RECALLING FIRM/MANUFACTURER Abbott Health Products, Inc., Barceloneta, PR.
REASON Assay may give elevated patients results.
VOLUME OF PRODUCT IN COMMERCE 7,830 kits.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Protege GPS Biliary Stent System (6Fr 9mm x 30mm).
CODE SERB65-09-30-120 (.035) (Biliary) LOT #: 257441.
RECALLING FIRM/MANUFACTURER Ev3, Plymouth, MN.
REASON A customer complaint received indicated that a ProtÈgÈ stent, PN SERB65-09-30-120 was found in a pouch that was not properly sealed. The ProtÈgÈ GPS Stent System is 'double barrier' packaged and consists of a sealed inner tray in a sealed pouch. The pouch seal ensures sterility of the external surface of the inner tray. The inner tray seal containing the device was not affected.
VOLUME OF PRODUCT IN COMMERCE 5 systems.
DISTRIBUTION SC, NC, and TX.

PRODUCT Applied Blunt Tip Trocar Models C0717 and C0718.
CODE Trocars are assembled into procedure kits. Trocars have thier own serial number but the kit lots are relevant and include: 45036301001 to 45036301007 containing 1 each of lot 126803 = 71 each; 45208001001 to 452084001008 containing 1 each of lot 127322=8 each; 452451005001 to 452451005003 containing 1 each of lot 127322=3 each; 453029001001 to 453029001017 containing 1 each of lot 127322 = 17 each; 453715004002 containing 1 each of lot 126803 = 1 each; 454116005001 to 454116005002 containing 1 each of lot 127322 = 2; 454608003001 to 454608003006 containing 1 each of lot 172528 = 6 each.
RECALLING FIRM/MANUFACTURER Applied Medical Resources, Corp., Rancho Santa Margarita, CA.
REASON Inadequate trocar tip assembly that might yield parts to patients.
VOLUME OF PRODUCT IN COMMERCE 1,025 Systems.
DISTRIBUTION Nationwide and Ireland.

PRODUCT Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
CODE Lot 439010 Exp. 2006-11.
RECALLING FIRM/MANUFACTURER Biomet, Inc., Warsaw, IN.
REASON Mislabeled as to size; 1.55 mm pins are labeled as 2mm.
VOLUME OF PRODUCT IN COMMERCE 37 pins.
DISTRIBUTION CO, MS, MO, MT, NY, OH, PA, TX, and WI.

PRODUCT Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047.
CODE Lot Number: 30115.
RECALLING FIRM/MANUFACTURER CooperSurgical, Inc., Trumbull, CT.
REASON Product is mislabeled as a Mushroom Cap Vacuum but actually contains a Bell Style Assisted Delivery System.
VOLUME OF PRODUCT IN COMMERCE 495 units.
DISTRIBUTION Nationwide and Italy.

PRODUCT BC Thrombin Reagent. Thrombin Time Test.
CODE Lot 540624, Lot 540625, and Lot 540626.
RECALLING FIRM/MANUFACTURER Dade Behring, Inc., Newark, DE.
REASON The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients receiving heparin.
VOLUME OF PRODUCT IN COMMERCE 3,942 kits.
DISTRIBUTION CT, FL, IA, IL, NJ, PA, WI, and Internationally.

PRODUCT
a) Medtronic MiniMed Paradigm Model 712.
b) Medtronic MiniMed Paradigm Model 512.
CODE
a) Serial numbers that end in ì-Dxx3î. Where ìxî can be any number or letter;
b) Serial numbers that end in ì-Axx4î. Where ìxî can be any number or letter.
RECALLING FIRM/MANUFACTURER Medtronic MiniMed, Northridge, CA.
REASON Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed this only occurs when the pump is programmed to display information in Spanish.
VOLUME OF PRODUCT IN COMMERCE 10,600 units.
DISTRIBUTION Nationwide and Spain.

WEEK ENDING OCTOBER 23

PRODUCT
a) Mouse anti-TTF-1 concentrate used in a panel designed to differentiate between different types of cancer when used to
test a patient.
b) Mouse anti-TTF-1 2nd Gen Predilute used in a panel designed to differentiate between different types of cancer when used to
test a patient.
CODE
a) Product Number 18-0221, no 510(k) number, Product Code MXZ, lot code 40280262;
b) Product Number 18-1221, no 510(k) number, Product Code MXZ, lot code 40180205.
RECALLING FIRM/MANUFACTURER Zymed Laboratories Inc., South San Francisco, CA.
REASON Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings.
VOLUME OF PRODUCT IN COMMERCE 24 vials of concentrate, and 4 vials of 2nd Gen Predilute.
DISTRIBUTION MD, GA, TX, OH, IL, DC, NY, CA, France, Portugal, China, Italy, Israel, Philippines, and Germany.

PRODUCT Aeroset Analyzer Systems Operation Manual.
CODE All Systems Operations Manuals.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX.
REASON Changes to the printer default settings made by users/operators cause printed data to be truncated and misidentified.
VOLUME OF PRODUCT IN COMMERCE 736 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8", Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034.
CODE Lot Numbers: 3LR240, 3NR190, 3SR074, 4AR119, 4BR187, 4CR290.
RECALLING FIRM/MANUFACTURER Fresenius Medical Care North America, Lexington, MA.
REASON Peritoneal Dialysis Transfer Set may have occluded pathway.
VOLUME OF PRODUCT IN COMMERCE 3,510 units.
DISTRIBUTION Nationwide and Canada.

PRODUCT Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
CODE Serial Number: MC02017-I3; MC02134-I3; MC02138-I3; MC02148-I3; MC02321-K3; MC02002-I3; MC02005-I3; MC02006-I3; MC02008-I3; MC02020-I3; MC02023-I3; MC02025-I3; MC02027-I3; MC02030-I3; MC02034-I3; MC02043-I3; MC02044-I3; MC02048-I3; MC02052-I3.
RECALLING FIRM/MANUFACTURER Datascope Corp., Mahwah, NJ.
REASON Software anomaly where the variable heart rates may be displayed inaccurately or intermittent "dashes" may be displayed when the patient's heart rate is derived from ECG.
VOLUME OF PRODUCT IN COMMERCE 19 units.
DISTRIBUTION CA, IN and SC.

PRODUCT HealthPax (HP-1). Cranial Electrotherapy Stimulator GZJ.
CODE HP-1.
RECALLING FIRM/MANUFACTURER Health Directions, Inc., Morrisville, PA.
REASON Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device.
VOLUME OF PRODUCT IN COMMERCE 3,475 units.
DISTRIBUTION CA, MA, NJ, NY, PA, TX and WA.

WEEK ENDING OCTOBER 30

PRODUCT Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
CODE All serial numbers are being recalled.
RECALLING FIRM/MANUFACTURER General Electric Med. Systems LLC, Waukesha, WI.
REASON GE Healthcare received reports of intermittent low ejection fraction (EF) results for MUGA (multi-gated acquisitions) studies on Millennium VG systems. This issue can occasionally lead to distortions in the volume curve in some MUGA studies, and result in calculated EF values lower (never higher) than actual values. A low EF value could lead to a physician decision to stop needed treatment.
VOLUME OF PRODUCT IN COMMERCE 853 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000.
b) Stryker Navigation System - Hip Module Patient Tracker, blue; Model 6007-010-000.
CODE
a) Serial numbers PG04-0001 through PG04-0017;
b) Serial numbers PG04-0006 through PG04-0017.
RECALLING FIRM/MANUFACTURER Stryker Instruments, Instruments Div., Kalamazoo, MI.
REASON The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affect the patient tracker system.
VOLUME OF PRODUCT IN COMMERCE 17.
DISTRIBUTION Nationwide.

PRODUCT iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing wheelchair). Catalog No.'s IT000101-IT000148 (inclusive).
CODE Vehicle Identification Numbers ("VIN"s): 020404-000347, 020104-000309, 020504-000357, 021203-000308, 020204-000331, 020104-000314, 020104-000318, 021203-000301, 020304-000335, 020104-000310, 020404-000341, 021203-000299, 020204-000330, 020104-000322, 020204-000332, 020404-000350, 020404-000348, 020304-000340, 020404-000346, 020404-000342, 021203-000307, 020204-000333, 020104-000319, 021203-000304, 020404-000352, 020304-000337, 020304-000336, 020504-000356, 020404-000349, 021203-000305, 020604-000360, 020104-000317, 021203-000306, 020504-000358, 020404-000345, 020504-000354, 020304-000334, 020304-000338, 020404-000344, 020404-000351, 020504-000355, 020104-000323, 020104-000324, 021103-000291, 021203-000300, 020304-000339, 020404-000343, 020504-000359, 020604-000363, 020604-000364, 020604-000365, 020604-000366, 020604-000367, 020604-000368, 020604-000362, 021103-000290, 021103-000295, 020104-000315, 020104-000316, 020104-000320, 020104-000311, 020104-000313, 020204-000329, 020504-000353, 020104-000312, 020604-000361, 021003-000280, 020204-000328, 020104-000321, 020204-000326, 021203-000297, 021203-000298, 021203-000303, 020204-000327, 021103-000294, 021103-000286, 021103-000287, 021003-000273, 021103-000282, 021103-000292, 021103-000293, 021003-000276, 021003-000277, 021103-000285, 021103-000289, 020204-000325, 021103-000296, 021003-000278, 021003-000281, 021003-000272, 021003-000279, 021003-000274, 021003-000275, 021103-000283, 021103-000288, 021103-000284, 021203-000302.
RECALLING FIRM/MANUFACTURER Independence Technology LLC, Warren, NJ.
REASON Rocks and debris can enter into the wheel cluster housing through a damaged wheel cap causing wheel malfunction.
VOLUME OF PRODUCT IN COMMERCE 81 chairs.
DISTRIBUTION Nationwide, UK, Ireland, and New Zealand.

PRODUCT Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.
CODE Serial numbers 040639739, 040639849, 040639737, 040639738, 040639675, 040639674, 040639670, 040639671, 040639672, 040639716, 040639847, 040639848, 040639935, 040639936 and 040639937.
RECALLING FIRM/MANUFACTURER Stryker Medical, Kalamazoo, MI.
REASON Locking pins may be installed backward, and cot may drop from highest to lowest position when the users are not prepared for the drop.
VOLUME OF PRODUCT IN COMMERCE 15 units.
DISTRIBUTION AL, CA, FL, KS, MT, OK, TX and VA.

PRODUCT Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent contained in Becton Dickinson's BD Gram Stain Kits and Reagents, catalog #212539.
CODE Lots 4223220, Exp 5/28/05 4226886, Exp 5/28/05 4233156, Exp 5/28/05 4237134, Exp 6/30/05 4226882, Exp 5/28/05 4237144, Exp 6/30/05.
RECALLING FIRM/MANUFACTURER Becton Dickinson and Co, Sparks, MD.
REASON Reagent for microbiological testing may cause inconsistent staining characteristics and subsequent misidentification of bacteria in patient samples.
VOLUME OF PRODUCT IN COMMERCE 8,685 bottles.
DISTRIBUTION Nationwide and Internationally.

PRODUCT CryoValve, Pulmonary Valve & Conduit.
CODE Donor Number: 68668, Serial Number: 8037696, Model Number: PV00.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON A pre-implant swab culture of the aortic valve, which was procured from the same donor, was positive for Methicillin resistant Staphyococcus aureus.
VOLUME OF PRODUCT IN COMMERCE 1 tissue.
DISTRIBUTION CA.

PRODUCT SOLO-care® Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For soft lenses, Made in Canada, Assembled in Canada, The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.
CODE All sizes, configurations and all third part branded products.
RECALLING FIRM/MANUFACTURER Ciba Vision Corporation, Duluth, GA.
REASON Stability tests at 24 months revealed failing results for disinfection efficacy.
VOLUME OF PRODUCT IN COMMERCE 5,913,120 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT EP Healing Abutment -- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant. Product Code: THA54.
CODE Lot No. 249229.
RECALLING FIRM/MANUFACTURER Implant Innovations, Inc., Palm Beach Gardens, FL.
REASON The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted.
VOLUME OF PRODUCT IN COMMERCE 216 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, and 4.0.6.
CODE All serial numbers for versions 3.x, 4.0.5, and 4.0.6.
RECALLING FIRM/MANUFACTURER General Electric Medical Systems Information Technology, Milwaukee, WI.
REASON The following two conditions may occur with the printing of full disclosure strips and reports, printing of the alarm history events stored on a GE Unity Network Patient Data Server (PDS), and printing of caliper reports in the GE CIC Pro central station monitoring product, 1) a delay or cessation in updating portions of th display screen: or, 2) System reset/restart.
VOLUME OF PRODUCT IN COMMERCE 11,778 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Remel Chocolate Agar, catalog # 01301, containing 15 plates/pkg, for in-vitro diagnostic use.
CODE Lot #435902, Exp. 2004-11-04.
RECALLING FIRM/MANUFACTURER Remel, Inc., Lenexa, KS.
REASON The product does not perform as intended with some quality control organisms (Haemophilus influenzae).
VOLUME OF PRODUCT IN COMMERCE 308/15-plate packages.
DISTRIBUTION IA, KS, MO, FL, NY, IL, AR, TX, and OK.

Gillette Announces Recall of Oral-B CrossAction Power and PowerMAX Toothbrushes and Refills

Reports have been received concerning instances where the brush head of an Oral-B CrossAction Power or PowerMAX toothbrush has become loose in the mouth during brushing.

It is therefore recommend that consumers stop using the CrossAction Power or PowerMAX toothbrushes and brush refills to assist in brushing the teeth of people with special needs. No other Oral-B product is affected.

If you are currently using a CrossAction Power or PowerMAX to assist in brushing the teeth of a person with special needs, Oral-B will replace it -- at no charge -- with our Oral-B Advance Power 400, which is better suited for use in assisted-brushing environments because it has a brush head without a latch.

Please call 1-800-496-6557 between the hours of 9:00 AM and 5:00 PM (EST) on Monday through Friday and Oral-B will send you a prepaid mailing envelope to return your CrossAction Power or PowerMAX toothbrush to us. Once received, we will send you an Oral-B Advance Power 400 battery toothbrush.

Also, caregivers can find helpful information about brushing the teeth of people with special needs on the website of the American Dental Association:

http://www.ada.org/public/topics/special_needs.asp

General Information
Gillette is redesigning the brush heads for these toothbrushes to eliminate issues related to the unlatching of the brush head. The new brush head refills, when available, will fit into the current CrossAction Power and PowerMAX toothbrushes. The new Oral-B CrossAction Power and CrossAction PowerMAX toothbrushes and brush refills are scheduled to be available in stores in January 2005.

You can call 1-800-496-6557 as noted above if you have any questions regarding the use of these products or this notice.