JUNE 2005
WEEK ENDING JUNE 4
PRODUCT
Sodasorb Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with
an ethyl violet indicator which turns from white to violet as absorber is depleted;
Manufactured by: W.R. Grace & Co. - Conn., 6050 West 51st St., Chicago,
IL 60638; the product is packaged in pre-paks(pre-filled 2.5 lb. canisters,
12 per carton) and 5-gallon pails.
CODE
Pre-paks Lot CR10-P115-14, exp. 10/2006, and
5-gallon pail Lot CR09-P115-30, exp. 9/2006.
RECALLING FIRM/MANUFACTURER
Darex Container Products, Division of W.R. Grace & Co., Chicago, IL
REASON
Both lots were found to be out of specification due to an elevated level of
small particles (fines).
VOLUME OF PRODUCT IN COMMERCE
360 pre-packs and 18 5-gallon pails.
DISTRIBUTION
Nationwide.
PRODUCT
Style 363 Saline-Filled BIOCELL textured Breast Implants..
CODE
UF6328, UF6330, UF6331, UM5056, UM5057, UM5059.
RECALLING FIRM
Recalling Firm: Inamed Corp, Goleta, CA
Manufacturer: McGhan Medico, SA, Barreal de Heredia, Costa Rica.
REASON
Wrong size Implant was mislabeled with the wrong size.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
WI, TN, TX, NY, and AR.
WEEK ENDING JUNE 11
PRODUCT
Arrow Continuous Nerve Block Needle, Latex-Free, Rx only, Sterile.
CODE
Product #AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18040-N, AB-18080-N,
AB-18110-N, AB-18140-N, AB-19604-K, AB-19604-S, AB-19608-K, AB-19608-S, AB-20604-K,
AB-20604-S, AB-20608-K, AB-20608-S
RECALLING FIRM/MANUFACTURER
Arrow International Inc., Reading, PA
REASON
Possible difficulty in passing the catheter through the needle due to a reduced
ID of the needle caused by over crimping of the needle during the manufacturing
process.
VOLUME OF PRODUCT IN COMMERCE
8,058 units
DISTRIBUTION
Nationwide, Africa, France, Holland, and Rotterdam
PRODUCT
a) Baxter PosiFlow Access Device for IV Access; Product
code 2N9050; a single use, sterile device with PosiFlow
Positive Displacement Feature and Male Luer Lock
Adapter, 0.06 mL.
b) Baxter Extension Sets with PosiFlow Access Device for IV
Access; Product codes 2N9051, 2N9052, 2N9053, 2N9054,
2N9055, 2N9057; a single use, sterile fluid pathway
devices with PosiFlow Positive Displacement Feature.
CODE
All lots.
RECALLING FIRM
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL
Manufacturer: Baxter Healthcare Corporation of Puerto Rico, Aibonito, PR.
REASON
Inadequate directions for use resulting in fluid leaks, valves sticking in the
open position, and flow output restriction.
VOLUME OF PRODUCT IN COMMERCE
Not known
DISTRIBUTION
Nationwide
PRODUCT
Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access
Blanket. Use only with a Bair Hugger temperature management unit. Not sterile.
Do not use I f primary packaging has been previously opened or is damaged.
CODE
Lot numbers ranging from 9631 up to and including 9657
RECALLING FIRM/MANUFACTURER
Arizant Inc., Eden Prairie, MN
REASON
Air channel seals on a limited number of Bair Hugger Model 555 Pediatric underbody
blankets could separate when inflated with air from Bair Hugger warming unit.
This separation would create a bulging area in the blanket's air channels, which
could have a potential to shift the patient's position on the blanket.
VOLUME OF PRODUCT IN COMMERCE
88,320 blankets
DISTRIBUTION
Nationwide
PRODUCT
Discovery Channel brand 8-Way Massager with Heat; therapeutic massager; Model
Number 4196-1. The model number and date code are molded into the side of the
handle of the massager near the on/off switch. .
CODE
Date code 054
RECALLING FIRM
Recalling Firm: Wahl Clipper Corp, Sterling, IL
Manufacturer: Wahl Clipper Ningbo Ltd, Zhejiang, China.
REASON
The housing of the massager's heating applicator attachment may crack during
use. If the plastic housing cracks and breaks it could expose the user to live
electrical connections and pose a shock hazard.
VOLUME OF PRODUCT IN COMMERCE
4,200 plastic heat applicators
DISTRIBUTION
Nationwide and PR
PRODUCT
a) Aortic Valve & Conduit, Donor #77647, Model #AV00.
b) Pulmonary Valve & Conduit. Donor #77647, Model #PV00.
CODE
a) Serial #8461379;
b) Serial #8471383
RECALLING FIRM/MANUFACTURER Cryolife, Inc, Kennesaw, GA
REASON
Subsequent to tissue release, CryoLife received new information related to the
donor time of death, which caused the donor to no longer meet CryoLife's acceptance
criteria for warm ischemic time.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
IL, MT
PRODUCT
Zimmer brand fracture blade plate instrument Chisel, 95 degree, small; assembly
part 4705-03-10, catalog number 00-4705-003-10.
CODE
Chisel lot number 60048084
RECALLING FIRM
Zimmer Inc., Warsaw, IN,
REASON
The engraved calibration lines are incorrectly specified, which will result
in the user obtaining a reading that the chiseling removed material to a depth
10mm deeper than what was actually removed, thus guiding the user to select
a blade plate that is longer than will fit.
VOLUME OF PRODUCT IN COMMERCE
37
DISTRIBUTION
Nationwide and Canada
PRODUCT
Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01),
9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01).
CODE
Serial numbers for domestic units: A21000015, A21000016, A21000018, A23000040,
A23000042, A23000047, A24000051, A24000052, A24000054, A24000055, A24000056,
A24000057, A24000060, A24000061, A24000067, A24000073, A24000076, A24000077,
A24000084, A24000087, A24000096, A24000101, A24000104, A25000106, A25000108,
A25000110, A25000115, A25000116, A25000118, A25000126, A25000130, A25000131,
A25000133, A25000136, A25000137, A25000143, A25000144, A25000145, A25000146,
A25000147, A25000148, A26000153, A26000154, A26000157, A26000159, A26000160,
A26000161, A26000164, A26000165, A26000167, A26000170, A26000171, A26000173,
A26000176, A26000178, A26000179, A26000180, A27000181, A27000184, A27000186,
A27000188, A27000189, A27000192, A27000194, A27000197, A27000198, A27000200,
A27000202, A27000203, A27000204, A27000210, A27000211, A27000212, A28000220,
A28000226, A28000229, A28000230, A28000231, A28000235, A28000238, A28000241,
A28000243, A28000247, A28000250, A28000253, A28000255, A28000257, A28000260,
A28000262, A28000265, A28000267, A28000270, A28000273, A28000275, A28000276,
A28000277, A28000280, A28000281, A29000289, A29000290, A29000292, A29000300,
A29000310, A29000318, A29000319, A29000323, A29000325, A2A000327, A2A000330,
A2A000335, A2A000337, A2A000338, A2A000340, A2A000344, A2A000345, A2A000348,
A2A000349, A2A000350, A2A000353, A2A000354, A2B000358, A2B000365, A2B000372,
A2B000374, A2B000381, A2B000385, A2B000395, A2B000399, A2B000408, A2B000411,
A2B000420, A2C000437, A2C000438, A2C000439, A2C000440, A2C000441, A2C000443,
A2C000444, A2C000445, A2C000446, A2C000447, A2C000448, A2C000449, A2C000450,
A2C000451, A2C000452, A2C000455, A2C000456, A2C000457, A2C000458, A2C000459,
A2C000460, A2C000462, A2C000463, A2C000465, A31000466, A31000467, A31000468,
A31000470, A31000474, A31000475, A31000477, A31000478, A31000479, A31000480,
A31000481, A31000482, A31000488, A31000489, A31000491, A31000492, A31000493,
A32000483, A32000490, A32000495, A32000498, A32000499, A32000501, A32000502,
A32000505, A32000507, A32000509, A32000513, A32000515, A32000516, A32000517,
A33000523, A33000528, A33000534, A33000536, A33000540, A33000546, A33000549,
A33000550, A34000556, A34000557, A34000559, A34000560, A34000563, A34000565,
A34000567, A34000568, A34000577, A34000578, A34000582, A34000587, A34000588,
A34000589, A34000595, A34000596, A34000597, A34000599, A34000603, A34000606,
A34000607, A34000611, A34000612, A34000614, A34000615, A34000616, A34000621,
A34000623, A34000627, A34000628, A34000629, A35000630, A35000636, A35000637,
A35000641, A35000642, A35000643, A35000644, A35000645, A35000649, A35000650,
A35000652, A35000654, A35000659, A35000663, A35000664, A35000665, A35000669,
A36000670, A36000674, A36000677, A36000678, A36000687, A36000692, A36000694,
A36000702, A36000705, A36000706, A36000707, A36000716, A36000717, A37000720,
A37000721, A37000723, A37000732, A37000735, A37000736, A37000738, A37000743,
A38000753, A38000756, A38000760, A39000767, A39000769, A39000776, A39000778,
A39000780, A39000783, A3B000790, A3B000794, A3B000796, A3B000799, A3B000802,
A3B000804, A3B000806, A3C000812, A3C000813, A3C000824, A3C000825, A3C000826,
A3C000846, A3C000850, A3C000853, A3C000854, A41000858, A41000861, A41000865,
A41000869, A41000872, A41000873, A42000885, A42000887, A42000889, A42000891,
A42000892, A42000893, A42000894, A42000895, A42000896, A42000897, A42000898,
A42000899, A42000901, A42000903, A42000906, A42000907, A42000912, A42000913,
A42000916, A42000921, A42000922, A42000925, A42000928, A42000931, A42000932,
A42000934, A42000941, A42000945, A42000947, A42000952, A42000959, A43000980,
A43000982, A43000995, A43001003, A43001005, A43001006, A44001017, A44001018,
A44001019, A44001022, A44001026, A44001027, A44001028, A44001032, A44001038,
A44001045, A45001050, A45001051, A45001053, A45001058, A45001061, A45001066,
A45001073, A45001077, A45001084, A45001089, A45001100, A45001104, A45001106,
A45001112, A45001117, A46001125, A46001133, A46001142, A46001143, A46001144,
A46001157, A46001160, A46001177, A46001184, A46001193, A46001198, A47001201,
A47001208, A47001219, A47001225, A47001230, A47001235, A47001237, A47001245,
A47001247, A47001250, A47001253, A47001259, A48001271, A48001282, A48001283,
A48001284, A48001288, A48001290, A48001294, A48001295, A49001312, A49001313,
A49001327, A49001341, A4A001347, A4A001353, A4A001357, A51001373, A51001383,
A51001389
RECALLING FIRM/MANUFACTURER
Philips Ultrasound, Inc., Bothell, WA
REASON
The acoustic display of Mechanical Index and Thermal Index is inaccurate - two
transducers may exceed limits for acoustic intensity and MI.
VOLUME OF PRODUCT IN COMMERCE
1,225 units
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
VITROS VALP Reagent, REF 680 1710. Each box contains 6 packs. Each pack contains
liquid reagent for 50 tests. .
CODE
01-5871, Exp. 31Jan06
RECALLING FIRM
Ortho-Clinical Diagnostics, Rochester, NY
REASON
Negatively biased results may be observed when the reagent is stored on the
VITROS 5,1FS Chemistry System for less than seven days.
VOLUME OF PRODUCT IN COMMERCE
139 boxes
DISTRIBUTION
Nationwide, England, France and Spain
PRODUCT
a) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit,
ID 7.0mm Product Number: 535070.
b) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit,
ID 8.0mm Product Number: 535080.
c) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 9.0mm Product Number: 535090.
d) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 7.0mm Product Number: 538070E.
e) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 8.0mm Product Number: 538080E.
f) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit,
ID 9.0mm Product Number: 538090E.
CODE
a) Lot Numbers: K518075, K520177, K548751, K573622,
K614995;
b) Lot Numbers: K515073, K515074, K515075, K518076,
K518077, K520176, K523556, K527903, K548745, K559483,
K614996, K630177;
c) Lot Numbers: K515076, K518078, K558496, K586109,
K614402, K629274;
d) Lot Number: K510891;
e) Lot Numbers: K510892, K565595;
f) Lot Number: K510893
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Keene, NH
REASON
Guiding catheter may have thinner and weaker sidewalls than designed, and may
break.
VOLUME OF PRODUCT IN COMMERCE
2,572 cases
DISTRIBUTION
Nationwide, Canada, Mexico and East Timor
PRODUCT
Mick TP Prostate Seeding Needles, 18 Gauge, Catalog/Model Number MTP-1820-C.
--- Brand Name: Mick TP Disposable Needle 18 Gauge. Common/Usual Name: TP Needle
18 Gauge. Classification Name: System, Applicator, Radionuclide, Manual. The
needle is an accessory to the Mick 200-TPV Applicator and Kit. This one time
use needle is used for brachytherapy. The product is sold in cartons with each
carton containing a total of 25 needles. Each carton contains 4 packages of
5 needles, and 5 packages containing one needle each.
CODE
Lots: M121504-07 (Exp. 12/15/2009), M012605-01 (Exp. 1/26/2010), M012805-01
(Exp. 1/28/2010).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mick Radio Nuclear Instruments, Inc., Mount Vernon, NY
Manufacturer: Manan Medical Products, Inc., Wheeling, IL.
REASON
Some of the Mick TP Prostate Seeding Needles do not fit properly into the Mick
200-TPV Applicator.
VOLUME OF PRODUCT IN COMMERCE
327 cartons.
DISTRIBUTION
Nationwide, Sweden and The Netherlands.
PRODUCT
Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x 1", Catalog
Number: 4238.
CODE
Lot Number: K621494.
RECALLING FIRM
Smiths Medical ASD, Inc., Keene, NH
REASON
Mislabeled: Product may contain an incorrect needle size. Product labeled as
a 25G x 1" may contain a 25G x 5/8".
VOLUME OF PRODUCT IN COMMERCE
159 cases (400 per case) = 63,600 each.
DISTRIBUTION
Nationwide.
WEEK ENDING JUNE 18
Qualitest Pharmaceuticals, Inc. Issues a Voluntary Nationwide Recall of Accusure Insulin Syringes 1cc 28 Gauge 1/2 Inch 100's
Qualitest Pharmaceuticals, Inc., today has issued a voluntary nationwide recall of Accusure Insulin Syringes 1cc, 28 Gauge l/2 Inch, distributed between October 2004 and June 2005. There may be 1cc syringes which are mislabeled as 1/2 cc syringes on the plastic inner wrap holding 10 individual syringes, which could potentially result in confusion by the patient or caregiver, resulting in an incorrect dose or amount being administered.
Consumers who have any of the product on hand should immediately stop using, and contact Qualitest, or return unused syringes to the pharmacy from which purchased.
Product was distributed to drug wholesalers/distributors, and pharmacies within the United States.
The product affected is as follows:
NDC 0603-6996-21 Accusure Insulin Syringes 1cc 28 Gauge 1/2 Inch Boxes of 100 (all lots)
Qualitest is notifying all customers who received the product and arranging for return of any affected product.
Consumers with questions may contact the company at 1-800-444-4011 for more
information.
PRODUCT
Nichols Advantage Sample hGH Diluent Set, Catalog No. 62-7756.
CODE
All codes
RECALLING FIRM/MANUFACTURER
Nichols Institute Diagnostics, San Clement, CA
REASON
Under recovery of diluted samples by as much as 20%.
VOLUME OF PRODUCT IN COMMERCE
Not specified
DISTRIBUTION
Nationwide, Germany, Sweden, Italy, Japan and Spain
PRODUCT
Nichols Advantage TSH -- Third Generation.
CODE
Lots 62-400791 and 62-400796
RECALLING FIRM
Nichols Institute Diagnostics, San Clement, CA
REASON
Does not meet performance claims in the labeling for analytical and functional
sensitivity.
VOLUME OF PRODUCT IN COMMERCE
1,072
DISTRIBUTION
Nationwide, Germany, Greece and Spain
PRODUCT
a) UNO 102 EM/EE/ES Patient Lift.
b) UNO 100 EM/EE Patient Lift.
c) Sabina I and II EM/EE Patient Lift.
CODE
a) Serial Numbers: Range 33590-42291;
b) Serial Numbers: Range 7090602-7093161;
c) Serial Number: Range 401205-41442
RECALLING FIRM/MANUFACTURER
Recalling Firm: Liko, Inc, Franklin, MA
Manufacturer: Liko Ab, Lulea, Sweden.
REASON
Incorrect length support screws may cause patient lift failure.
VOLUME OF PRODUCT IN COMMERCE
950 units
DISTRIBUTION
Canada
PRODUCT
Servo-I Ventilator.
CODE
All Servo-i units with serial numbers below 17617
RECALLING FIRM
Recalling Firm: Maquet Inc, Bridgewater, NJ
Manufacturer: Maquet Critical Care AB, Solna, Sweden.
REASON
Complaints about batteries indicating a satisfying remaining time but after
a short time suddenly shut off without giving alarms to indicate short remaining
battery back-up time. (Power off alarm will be given).
VOLUME OF PRODUCT IN COMMERCE
4379 units
DISTRIBUTION
Nationwide
PRODUCT
Perkin ELmer Life and Analytical Sciences - NeoGram Amino Acids and Acylcarnitines
Tandem Mass Spectrometry Kit.
CODE
Catalog Number: MS-8970 Lot numbers: 252208, 257031, 258928, 258937, 259588,
263097, 267166, 267628, 268256, 268258, 268403, 268404, 268675
RECALLING FIRM/MANUFACTURER
Recalling Firm: Perkin Elmer Life and Analytical, North Billerica,
MA
Manufacturer: Perkin Elmer Life Sciences, Turku, Finland.
REASON
Pump failure may affect data integrity.
VOLUME OF PRODUCT IN COMMERCE
622 kits
DISTRIBUTION
AL, CA, CT, FL, IN, LA, GA, MI, MO, NJ, OR, SC
PRODUCT SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System.
CODE
All devices lot number 10RY and earlier of the following part numbers were removed
from the market in 2002: 407-1020; 407-1022; 407-1024; 407-1026; 407-1028; 407-1030;
407-1032; 407-1034; 407-2236; 407-2238; 407-2240; 407-2242; 407-2244; 407-2246;
407-2248; 407-2250; 407-2252; 407-2254
RECALLING FIRM
Spinal Concepts, Inc, An Abbott Laboratories Company, Austin, TX
REASON
Complaints were received where swivels came out of plate and where the screw
went through the plate.
VOLUME OF PRODUCT IN COMMERCE
28 Parts (total of 10 Systems)
DISTRIBUTION
CA, IL, IN, NC, MS, PA, NY and VA
PRODUCT
a) Roche brand AccuData GTS Plus System; Catalog number
3000249, material number 03000249001.
b) Roche brand AccuData GTS System; Catalog number 404,
material number 03136833001.
c) Roche brand AccuData GTS/GTS Plus System Replacement
Base/Module; Catalog number 3426050, material number
03426050001.
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN.
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany.
REASON
If foil wrapped packages or other metallic objects are lodged behind the supply
drawer, an electrical short may result and high heat generated; this could result
in plastic melting and battery leakage for customers using 'C' cell batteries
to power their base and could render the system inoperable (system won't turn
on) for customers using the A/C adaptor without batteries.
VOLUME OF PRODUCT IN COMMERCE
39000 units
DISTRIBUTION
Nationwide and Guam
PRODUCT
IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.
CODE
Lot No. 103-05
RECALLING FIRM/MANUFACTURER
International Remote Imaging Systems Inc, Chatsworth, CA
REASON
Nonconformance to performance specifications. The instrument failed to report
a positive result for nitrite which was expected for a conforming part B control.
VOLUME OF PRODUCT IN COMMERCE
107 units
DISTRIBUTION
Nationwide
Qualitest Pharmaceuticals, Inc. Issues a Voluntary Nationwide Recall of Accusure Insulin Syringes 1cc 28 Gauge 1/2 Inch 100's
Qualitest Pharmaceuticals, Inc., today has issued a voluntary nationwide recall of Accusure Insulin Syringes 1cc, 28 Gauge l/2 Inch, distributed between October 2004 and June 2005. There may be 1cc syringes which are mislabeled as 1/2 cc syringes on the plastic inner wrap holding 10 individual syringes, which could potentially result in confusion by the patient or caregiver, resulting in an incorrect dose or amount being administered.
Consumers who have any of the product on hand should immediately stop using, and contact Qualitest, or return unused syringes to the pharmacy from which purchased.
Product was distributed to drug wholesalers/distributors, and pharmacies within the United States.
The product affected is as follows:
NDC 0603-6996-21 Accusure Insulin Syringes 1cc 28 Gauge 1/2 Inch Boxes of 100 (all lots)
Qualitest is notifying all customers who received the product and arranging for return of any affected product.
Consumers with questions may contact the company at 1-800-444-4011 for more information.
FDA Issues Nationwide Notification of Recall of Certain Guidant Implantable Defibrillators and Cardiac Resynchronization Therapy Defibrillators
FDA is notifying health care providers and patients that the Guidant Corporation is recalling certain of its implantable defibrillators and cardiac resynchronization therapy defibrillators. These devices can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed.
The devices affected by this notification are:
The devices are surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm). The devices deliver an electrical shock to the heart to restore normal heart rhythm. The PRIZM 2 and RENEWAL devices are subject to different failures, resulting in the devices' inability to deliver an electrical shock during episodes of arrhythmia -- which could lead to a serious, life-threatening event for a patient. There have been two deaths reported to FDA suspected to be associated with this malfunction.
FDA is not making a recommendation on whether individual patients who have one of the Guidant devices should have it removed and replaced. This is a decision that should be made by a patient in consultation with his or her physician, based on the specific medical situation of the patient. Removal and replacement of the device may pose some risk, so it is important that patients and physicians carefully discuss this matter before making a decision.
FDA advises patients to take the following steps:
Guidant also recently informed FDA that it is recalling another set of defibrillator devices called PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT. The company has said the devices are subject to a memory error, which may affect device performance. Currently, FDA is evaluating this information.
If you are a physician or a patient who has experienced a problem with any of these defibrillators, please send a report to FDA's MedWatch program and to Guidant. See http://www.fda.gov/medwatch/index.html for filing information or call 1-800-FDA-1088 (1-800-332-1088).
Guidant will be posting information for physicians on its web site at http://www.guidant.com/.
If you have further questions, you may contact Guidant at 1-866-GUIDANT (1-866-484-3268).
WEEK ENDING JUNE 25
PRODUCT
a) Clinical
Technologies, Inc., 25 G Spinal Painpak, Reorder No.: 4043.
b) 22G Nerve Block
PainPak, Reorder No.: 3269.
CODE
a) Lot number 1004328;
b) Lot numbers:
0804370, 0904191, 0904014, and 0904207; Lot number: 0904239; Lot
numbers 1104306, 0305143,
and 0105001
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Spinal Specialties, Inc., San
Antonio, TX,
Manufacturer: Becton Dickinson
& Co, Franklin Lakes, NJ.
REASON Becton Dickinson recalled the needles due
to reports of leakage associated with an undersized Luer taper in the spinal
needle hub.
VOLUME OF PRODUCT IN COMMERCE 642
kits
DISTRIBUTION VA, OH, TX, CA, IL, and
FL
PRODUCT LifeScan
brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part
Number 020-244-07;
CODE OneTouch
Ultra Test Strip Lot: 1022859; [A second lot (# 1022865) was also mislabeled
with the incorrect Control Solution range. This lot was distributed outside of
the US, exclusively in Italy.]
RECALLING FIRM LifeScan,
Inc., Milpitas, CA,
REASON A Control Solution range for the
OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL.
VOLUME OF PRODUCT IN COMMERCE
8,718 boxes
(containing 435,900 test strips)
DISTRIBUTION Nationwide
and Italy
PRODUCT
a)
Hitachi Altaire Magnetic Resonance Imaging Device.
b)
Hitachi AIRIS II Magnetic Resonance Imaging Device.
c) Hitachi AIRIS Elite Magnetic Resonance Imaging Device.
CODE
a) L001 thru L182;
b)
C002 thru C795, C907, and C910;
c) H003 thru H059
RECALLING
FIRM/MANUFACTURER Hitachi Medical Systems America Inc., Twinsburg, OH
REASON
Image reconstruction software problem
that could potentially cause multiple patient images to be stored in one patient
folder.
VOLUME OF PRODUCT IN COMMERCE 983
devices
DISTRIBUTION Nationwide, Wales and
London
PRODUCT
a) Peri-Strips Dry with Veritas Collagen Matrix Staple
Line Reinforcement (PSD-V), 4506 ETS-V. PSD-V is an implantable surgical mesh comprised of
non-crosslinked bovine pericardium in a dehydrated form. Do not reuse. Consult Instructions for Use. Sterilized. Product
treated with sodium
hydroxide. Product derived from USDA-inspected cattle. Made in the U.S.A. Rx
Only.
b) Peri-Strips Dry with Veritas Collagen Matrix
Staple Line Reinforcement (PSD-V), 4506 E-V. PSD-V is an implantable
surgical mesh comprised of non-crosslinked bovine pericardium in a
dehydrated form. Do not reuse.
Consult Instructions for Use. Sterilized.
Product treated with sodium hydroxide. Product derived from USDA-inspected cattle. Made in the U.S.A. Rx Only.
CODE
a) Lot Number: 5707464-166925, 5707598-118352,
5708605-151644, 5708622-152524, 5708624-152526, 5709355-167627,
5709825-173142, 5709826-173143 and 5709827-173144;
b) Lot number:
5707471-116932, 5707579-118319 and 5709356-167628
RECALLING
FIRM Synovis Surgical Innovations A Division of Synovis Life
Technologies, Inc., St. Paul, MN,
REASON Device is
contained in 2 pouches. The outer pouch’s seal may be compromised; this may
render the exterior of the interior pouch non-sterile.
VOLUME OF
PRODUCT IN COMMERCE 376 boxes
DISTRIBUTION Nationwide