WEEK ENDING SEPTEMBER 3

PRODUCT Indigo Bare-Tip fiberoptic
CODE LF020
MANUFACTURER Ethicon Endo-Surgery, Inc. Albuquerque, NM
RECALLED BY Indigo Medical, Inc., Cincinnato, Oh.
DISTRIBUTION TN, PA, AR, KY and NY.
QUANTITY 9 units
REASON I fiberoptic tip is contaminated.

PRODUCT a)Rotablator RotaLink Plus Pre-connected Exchangeable Rotational Atherectomy System; b)Rotational RotaLink Coronary Advancer; c)Rotablator RotaLink Peripheral Adavncer
CODE Cat NOS.a) 23631-002-23631-007, 23631-015, 23631-016, b) 22782-001A0, 22782-0010, c) 11381-90
MANUFACTURER Boston Scientific Corporation, Redmond, WA
DISTRIBUTION Nationwide.
REASON Braking mechanism may fail to secure guidewire during use.

PRODUCT 3-D Imgcomp Utility User Manual Update, Z-1223-9
CODE All Versions (2.72b & 3.07d)
MANUFACTURER Precision Therapy International, Inc., Norcross, GA
DISTRIBUTION Nationwide and international.
QUANTITY 190 Manuals
REASON A design error may lead to a serious miscalculation of radiation dose.

PRODUCT Mimi-Acutack 1.5 mm Cannulated Hex Driver Tip, Part #HAD-L-0815.
CODE HWC
MANUFACTURER ACUMED, INC., Beaverton, OR.
DISTRIBUTION Nationwide.
QUANTITY 4 each.
REASON The Hex driver tips may prevent the Mini-Acutrak Bone Screw from seating properly.

PRODUCT CryoValve (Heart valve)
CODE Model no. AV00, Serial No. 6222366 Model no. PV00, Serial No. 6222374
MANUFACTURER Cryolife, Inc., Kennesaw, GA
DISTRIBUTION Nationwide.
QUANTITY 1 each
REASON Does not meet current guidelines regarding serodilution of plasma.

PRODUCT STRAUMANN INTRAsurg 500, an AC powered drilling device intended to supply power to and serve as a base for other dental devices such as a dental handpiece during dental and maxillofacial surgery.
CODE Serial #ís: 824-828, 830, and 831.
MANUFACTURER KAVO DENTAL GmBH Biberach-Riss, Germany
RECALLED BY The Straumann Co., Waltham Massachusetts
DISTRIBUTION Arizona, California, Deleware, Massachusetts, Montana, Texas.
QUANTITY 7 Units were distributed.
REASON Software error may cause unit to shutdown prior to reaching preset torque limit.

PRODUCT APLIGRAF (GRAFTSKIN), indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficiency of greater than 1-month duration which has not responded to conventional therapy.
CODE LOT NUMBER: GS9906.22.03.1A Unit Numbers: 42, 43,45, 46, 47, 50, 52-74, and 76
LOT NUMBER: GS9906.22.03.2A Unit Numbers: 1, 3, 5, 6, 9, 10, 11, 12, 13, 15, 16, 17, 18, 19, 21, 22, 23, 24, 25, 26,28, 29, 30, 31, 32, 34, EXP 7/22/99.
MANUFACTURER ORGANOGENESIS INC. CANTON,Massachussets
RECALLED BY Novartis Pharmaceuticals Corp. (Global Distributor), East Hanover, New Jersey
DISTRIBUTION Alabama, Arizona, California, Georgia, Illinois, Indiana, New York, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, Ohio, Pennsylvania, South Carolina, Texas.
QUANTITY 58 units were distributed.
REASON products ph may be out of specification due to packaging error.
 

WEEK ENDING SEPTEMBER 10

PRODUCT Passport Recessed Patella Reamer Shaft
CODE Catalog No. 7650-1433(All Case Code Numbers)
MANUFACTURER Howmediea Osteonies, Allandale, NJ.
DISTRIBUTION Nationwide.
QUANTITY 120 each.
REASON Case slippage of the reamer stop component which results in removal of to much material from the patella.

PRODUCT Model 1200 Mini Digital Hanging Scale
CODE All serial numbers
MANUFACTURER Integrated Measurement Systems, Inc., Elk Grove Village, IL.
DISTRIBUTION Nationwide.
QUANTITY 113 scales.
REASON The scale may disconnect fro the lifter boom.

PRODUCT Hemodialysers
CODE Lot: 757980911A.
MANUFACTURER Althin Medical, Inc., Miami Lakes, FL.
DISTRIBUTION Senko Medical Instrument Mfr., Toyko Japan.
QUANTITY 3876 units.
REASON Crack blood ports which may compormise the sterility barrier and cause leakage.

PRODUCT Tracheostomy Care Trays (Sterling Disposable Products)
CODE Catalog #4118, 4120, 4125, 4128, RW031 Lot numbers:
a)standard tray, 24 per case: Catalog #4118, lots RJ0028, RJ0030, RJ0031, SC1522, SD1523, SD1524, SE1525; also reorder #RW031, lots RJ0036, RJ0038, SC1635, SD1644;
b)Deluxe Tray, w/extra towel and pipe cleaners, 24 per case: Catalog #4120, lots RJ0026, RJ0034, SC1526, SD1528, SD1655, SE1527, SE1529, RP0105, RP0108;
c)Standard Tray w/forceps and CSR Wrap, 20 per case: Catalog #4125, lot SD1575;
d)Standard Tray w/Hydrogen Peroxide, 20 per case: Catalog #4128, lots RJ0021, RJ0022.
MANUFACTURER Sterling Disposable Products, Inc., Chicago, Ill.
RECALLED BY Premium Plastics, Chicago, Ill.
DISTRIBUTION Nationwide.
QUANTITY 122,840 trays.
REASON Trays were contaminated with ETO resistant mold.
 

WEEK ENDING SEPTEMBER 17

PRODUCT Percutaneous Sheath Introducer Kit, Catalog #AK-09903-S.
CODE Lot numbers: 9E4846, 9E8190, and 9E8305.
MANUFACTURER Arrow Intl., Inc., Reading, Pennsylvania.
DISTRIBUTION Nationwide.
QUANTITY 9,380 units were distributed.
REASON The dilator may not pass over the 0.035" spring wire guide.

PRODUCT ACQPLAN, Radiation Therapy Planning System, a software option for the Computed Tomography (CT) Scanners
CODE All serial numbers.
MANUFACTURER Picker International, Inc., Highland Heights, Ohio.
DISTRIBUTION Georgia, California, Pennsylvania, Florida, Canada, Switzerland.
QUANTITY 11 systems were distributed.
REASON An incorrect calculation of Iso/N dosage may result when changing parameters.

PRODUCT CT Lemage/Prospeed and CT Legato/Sytec SRi Computed Tomography Scanners
CODE
Lemage: Model Serial #'s 2175677 406709YM6-406785YM6, 467161YM6-467184YM8, 2137876-2 332195YM7-332294YM8, 350363YM8-350414YM9, 411513YM5-`11523YM4, 2144046 314539YM8-314554YM7, 2137876 314339YM3-314371YM6, P9201AA 176771YM4-207931YM7, 2117432 276855YM4-276905YM7, 2132953 292916YM4-292939YM6
Prospeed: 2175679 406808YM6-406907YM6, 435774YM5-435873YM5, 459985YM8-460041YM7, 486537YM4-486661YM2,
2137877-2 332295YM5-332391YM2, 350162YM4-350233YM3, 389452YM4-389546YM3, 213877 314439YM1-314480YM5, P9201AB 169386YM0-169457YM9, 261127YM5-261134YM1, P9201AC 169486YM8-169561YM8, 249625YM5-249641YM2, 2117433 276955YM2-298889YM7
Legato 2137295 313939YM1-313960YM7, 2174625 386246YM3-386330YM5, 469090YM5-469093YM9, 2107485 196180YM4-196707YM4,
2121800 286716YM6-286724YM0
Sytec SRi 2137296 314039YM9-314116YM5, 376750YM6-376775YM3, 2107487 196181YM2-196182YM0, 196736YM3-196785YM0
232601YM5-232618YM9, 2121801 286816YM4-286849YM5.
MANUFACTURER GE-YMS, Ltd., Hino-Shi, Tokyo, Japan.
RECALLED BY General Electric Medical Systems, Waukesha, Wisconsin
DISTRIBUTION Nationwide and international.
QUANTITY 1,375 units were distributed.
REASON The table cradle stopped moving and the system continued to emit radiation, resulting in the patients being exposed to X-rays at the same location for more than one scan.

PRODUCT Sterile Bag Decanter, Part #10-102
CODE 08237C0580, 08237C0582, 08237C0585, 08364C0883, 08381C0889, 08381C0980, 08508C1289, 08508C1381, 08508C1385, 08630C1585, 08630C1588, 08630C1680, 08702C1784, 08702C1785, 08702C1787, 08672C1689.
MANUFACTURER Advance Medical Designs, Inc., Marietta, Georgia.
DISTRIBUTION Nationwide and Canada.
QUANTITY 649,100 units were distributed.
REASON The devices would fall apart due to inadequate gluing of components.
 

WEEK ENDING SEPTEMBER 24

PRODUCT Rotabulator Rotalink, indicated for use in patients with coronary artery disease:
a) Rotablator RotaLink Plus Pre-connected Exchangeable Rotational Atherectomy System with Catalog Nos. 23631-002, 23631-003, 23631-004, 23631-005, 23631-006, 23631-007, 23631-015, 23631-016;
b) Rotablator RotaLink Coronary Advancer with Catalog Nos. 22782-001A0, 22782-0010;
c) Rotablator RotaLink Peripheral Advancer with Catalog No. 11381-90, intended for percutaneous use in peripheral vessels in patients with occlusinve atherosclerotic disease who are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty.
CODE All lot numbers.
MANUFACTURER Boston Scientific Corporation Northwest, Redmond, Washington.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 35,000 coronary devices and 280 peripheral advancers were distributed.
REASON The braking mechanism may fail to secure the guidewire during use, which can cause the guidewire to move suddenly, resulting in vessel damage.

PRODUCT EPROM Version 3.00 Software for the Olympus EVIS CV-140 Video System Center, an endoscopic video imaging system that provides photo/video documentation of the upper lower gastrointestinal tract using the EVIS 140 series video endoscopes.
CODE Catalog #3010, Serial numbers: 7834678 to 7948133.
MANUFACTURER Shirakawa Olympus Company, Ltd., Japan.
RECALLED BY Olympus America Inc., Melville, New York
DISTRIBUTION Nationwide and international.
QUANTITY 1,430 units were distributed.
REASON The device has a malfunction due to incorrect coding of the software, which can cause the software to overwrite the patient ID number with any comments that are entered by the user.