WEEK ENDING JUNE 4

PRODUCT Scimed Ranger 20 mm Percutaneous Transluminal Coronary angioplasty (PTCA) Dilatation Balloon Catheter.
CODE Model: H74914361251, Lot numbers: 2293535 and 2293538.
MANUFACTURER Boston Scientific Corporation, Ireland, Ltd., Galway, Ireland.
RECALLED BY Boston Scientific /Scimed, Maple Grove, Minnesota
DISTRIBUTION Nationwide.
QUANTITY 54 catheters were distributed.
REASON The wrong/unvalidated sterilization process was used for the two recalled lots.

PRODUCT Innovative Implants and Cover Screws.
CODE Catalog #OSS610, Lot #77963.
MANUFACTURER Implant Innovations, Inc., Palm Beach Gardens, Florida.
DISTRIBUTION New York, Illinois, Germany, Japan.
QUANTITY 25 implants.
REASON Product was mislabeled as 6.0mm when it was actually 5.0mm.

PRODUCT Model Visulas Laser System, used in ophthalmology: a) Model No. 532; b) Model No. 532 Combi; c) Model No. 690s; d) Model No. 732S; e) Model Yag II Plus.
CODE a) Model No. 532; b) Model No. 532 Combi; c) Model No. 690s; d) Model No. 732S; e) Model Yag II Plus.
Serial numbers; 1468 thru 1502, 79600, 79601, 79602, 79605, 79606, 79610 thru 79631, 79805 thru 79808
MANUFACTURER Carl Zeiss, Inc., Thornwood, New York.
DISTRIBUTION Nationwide, Argentina, Canada, Europe
QUANTITY 67 units were distributed.
REASON Device failed to comply with 21 CFR 1040.11(a)(2) in that the operator's manual lacked calibration procedures.

PRODUCT Model CVX-300 Excimer Laser, used in cardiology.
CODE Model CVX-300. (ANY SERIAL NUMBERS?)
MANUFACTURER Spectranetics Corporation, Colorado Springs, Colorado.
DISTRIBUTION Nationwide.
QUANTITY 128 units were distributed.
REASON The device failed to comply with 21 CFR 1040.10(f)(1) in that the protective housing had a narrow gap allowing direct line-of-sight access to the Class IV beam.

PRODUCT Model E2000 Ruby Laser System.
CODE Model E2000.
MANUFACTURER Palomar Medical Products, Inc., Lexington, Massachusetts.
DISTRIBUTION Nationwide.
QUANTITY 7 units were distributed.
REASON The device failed to comply with 21 CFR 1040.11(a)(2) in that the operator's manual lacked calibration procedures.

PRODUCT Eagle 3000 Floorloader Steam Sterilizer.
CODE Various serial numbers.
MANUFACTURER Steris Corporation, Erie Pennsylvania.
RECALLED BY Steris Corporation, Mentor, Ohio
DISTRIBUTION Nationwide, Canada, Korea, Hong Kong, Taiwan.
QUANTITY 67 units were distributed.
REASON There is an error in the control system software, which causes the chamber temperatures to exceed the upper limit.

PRODUCT Tissue Suture Anchors, used to reattach soft tissue to bone during surgery: a) Part No. PAE5K - OBL RC5 R.0 mm Suture Anchor; b) Part No. PAS2K - PeBA S 2.8 mm Suture Anchor.
CODE Lot numbers: a) A1305B, A1205B, A1405B, A1505B, A0906B, A1006B, A1106B, A0708B, A0807BM, A1007B, A1507B, A2907B, A0211B, A0311B, A1612B, A1712B, A2701C, A2801C, A2901C, A3101C; b) A0406B, A1505B, A1905B, A0206B, A0806B, A1106B, A1806B, A1906B, A0607B, A0907B, A1607B, A0608B.
MANUFACTURER Southmedic, Inc., Ontario, Canada (assembler/packager).
RECALLED BY Orthopaedic Biosystems, Ltd., Inc., (OBL), Scottsdale, Arizona (specification developer/responsible firm)
DISTRIBUTUTION Nationwide.
QUANTITY 15,162 units were distributed.
REASON The sterility of the lots cannot be assured due to a packaging defect that occurred during the heat sealing process.

PRODUCT Portable Oxygen Generator: a) Model 5LX02; b) Model 6LX02.
CODE All codes manufactured between August 1998 through March 31, 1999.
MANUFACTURER Invacare Corporation, Sanford, Florida.
RECALLED BY Invacare Corporation, Elyria, Ohio
DISTRIBUTION Nationwide and international.
QUANTITY 29,106 units were distributed.
REASON Oxygen concentrators had a high incidence of reported circuit board failures.

PRODUCT Patient Scale, Model RSC600.
CODE All units manufactured between October 1, 1998 and March 31, 1999.
MANUFACTURER Invacare Corporation, Elyria, Ohio.
DISTRIBUTION Nationwide.
QUANTITY 188 units were distributed.
REASON Screw, which secures scale, may become disengaged, causing patient/occupant to fall from scale.

PRODUCT a) Cobe Renalyte Rx Acid Concentrate For Bicarbonate Dialysate, 2-K and 2.5 Ca, Product Number 012-116-004; b) Cobe Renalyte Rx Acid Concentrate for Bicarbonate Dialysate, 2-K, product number 012-111-004.
CODE Lot G8H074.
MANUFACTURER DiChem Concentrates, Inc., Lewisberry, Pennsylvania.
RECALLED BY Gambro Healthcare, Deland, Florida
DISTRIBUTION Massachusetts, Illinois, New Jersey, West Virginia, Pennsylvania, Connecticut, New York, South Carolina, Ohio, Delaware, Missouri, Virgin Islands.
QUANTITY 1,095 cases (4 one-gallon bottles per case) were distributed.
REASON Some product was mislabeled as product code 012-111-004 bicarbonate dialysate.
 

WEEK ENDING JUNE 11

PRODUCT Hemoglobin Reagent
CODE HEC-506, Lot: #801164, Expiration: 1 JAN 2000.
MANUFACTURER EG & G Wallace, Inc., Norton, Ohio.
RECALLED BY EG & G Wallace, Inc., Akron, Ohio
DISTRIBUTION Tennessee, Virginia, California, Illinois, Massachusetts, Nebraska, New York, Canada, Brazil.
QUANTITY 33 sets were distributed.
REASON Product is packaged with an insert sheet which incorrectly identifies the control as Hb A/S in the heading, instead of the correct control identification of Hb A/F.

PRODUCT Acoma X1000 Hydraulic Stand, Item #SSB-T0959-6, part of the Trans X-1000 Fully Automatic Chest X-ray system, intended for use in general radiographic applications. The Trans X-1000 is a fully automatic chest film changer. It provides a direct film transport mechanism between the film supply magazine and the film processor,.a fully automatic chest film changer.
CODE Serial numbers: 300002, 300007, 300010, 300011, 300012.
MANUFACTURER Canon, Inc., Tokyo, Japan.
RECALLED BY Canon USA, Inc., Lake Success, New York
DISTRIBUTION Missouri, Ohio, Florida, New York, Pennsylvania, Illinois.
QUANTITY 6 units were distributed.
REASON The arm support mechanism (handle) can break.

PRODUCT CMV IgM ELISA Test System, an enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to cytomegalovirus.
CODE Lot #9VIRO17456, Product #9Z9501M EXP 11/30/99.
MANUFACTURER Zeus Scientific, Inc., Branchburg, New Jersey.
DISTRIBUTION Nationwide, China, Indonesia.
QUANTITY 66 kits were distributed.
REASON The product may produce false positive test results.

PRODUCT Lasers and Laser Pointers:
a) Model No. LCM-T Lasers; b) Model No. LP-1M Laser Pointers; c) Model No. LP-2M Laser Pointers;
d) Model No. GP-2 (Pulsed) Laser Pointers.
CODE
a) Model No. LCM-T Lasers; b) Model No. LP-1M Laser Pointers; c) Model No. LP-2M Laser Pointers;
d) Model No. GP-2 (Pulsed) Laser Pointers.
MANUFACTURER Power Technology, Inc., Mabelvale, Arkansas.
DISTRIBUTION Nationwide.
QUANTITY 59 units were distributed.
REASON The LCM-T lasers were introduced into commerce uncertified and did not comply with the performance standard (Section 538 of the Federal Food and Drug and Cosmetic Act and 21 CFR 1010.2) The LP-1M and the GP-2 (pulsed) laser pointers exceeded the Class IIIa and Class II single pulse energy limits of the laser standard (21 CFRE 1040.10(c)(1). The LP-2M laser pointer failed to have a remote interlock connector, an adequate beam attenuator and the correct text on the warning logotype label (21 CFR 1040.10(g)(2)(iii).

PRODUCT Minnova Pelvic Floor Stimulation System; and InnoSense Pelvic Floor Stimulation and Electromyography System. Both systems use mild electrical stimulation to help control urinary incontinence.
CODE Affected Minnova serial numbers: 82004**, with the ** equal to 52, 53, 57, 59, 63-65, 67, 68, 70, 71, 73, 75, 76, 81-85, 87, 92, 93, 99, 82005**, with the ** equal to 10, 12-29, 31, 35-38, 41-50, 52-54, 58, 59, 64, 66, 68-74, 77-79, 81-84, 88, 89, 92, 95, 96, 98, 99, 82006**, with the ** equal to 03, 04, 06-10, 12-15, 17, 19, 21- 23, 42, 68, 73-77, 83, 95-99, 8200700
The affected InnoSense serial numbers are:
8000499, 80005**, with the ** equal to 00-11, 13-20, 24, 93, 8000602, 80506**, with the ** equal to 51-71, 80507**, with the ** equal to 49-58, 60-62, 71-74, 76-86.
MANUFACTURER EMPI, Inc., St. Paul, Minnesota.
DISTRIBUTION Nationwide and international.
QUANTITY 126 Minnova devices and 73 InnoSense devices were distributed.
REASON An oversized dimension of an electrical pin connector in a socket in each device will result in an incorrect electrical connection between the patient electrode and the device.

PRODUCT Get Smart Be Prepared, 207 piece Emergency First Aid Kit.
CODE Not coded -- Only the kits with a red cross on the label are subject to recall.
MANUFACTURER Total Resources International, Inc., Walnut, California.
DISTRIBUTION Pennsylvania, Maryland, Mississippi, Missouri, Arkansas, Louisiana, Texas.
QUANTITY 5,000 first aid kits were distributed.
REASON The Povidone Iodine pads in the kits are contaminated with microorganisms such as
 Pseudomonas putida, Salmonella spp., Poly D, and Aeromonas sorbia.


PRODUCT IiRAD DR1000C Digital Chest System, general purpose x-ray device. 
CODE Model IiRAD DR1000C.
MANUFACTURER Fischer Imaging Corporation, Denver, Colorado.
DISTRIBUTION Nationwide.
QUANTITY 2 units were distributed.
REASON The units are defective under 21 CFR 1003.2 in that they do not assure certification to field
 sizing specifications are met because the system intermittently opens wide open in the vertical direction 
when the exposure button is depressed.  This can result in the patient receiving excess exposure where 
no useful diagnostic imaging can occur.


PRODUCT CryoValve Allograft (heart valve), Model PV00.  
CODE Serial number 6553109.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Utah.
QUANTITY 1 unit was distributed and subsequently destroyed.
REASON The donorís final autopsy report, which included a histological exam of the donorís brain, 
revealed evidence of viral encephalitis.


PRODUCT CryoValve Allograft (heart valve), Model PVOO.
CODE Serial #6406157.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON The donorís final autopsy report revealed undiagnosed   Sarcoma (Fibrosarcoma) of the
right leg.


PRODUCT CryoValve Allograft (heart valve): 
a) Model No. AV40, Serial No. 6285082; b) Model No. AV05, Serial No. 6314988
CODE a) Serial No. 6285082; b) Serial No. 6314988.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION a) Maryland; b) Texas.
QUANTITY 1 unit of each component was distributed.
REASON The donors do not meet current guidelines regarding serodilution of plasma because of 
 the amount of transfused/infused fluids administered.
 
 

WEEK ENDING JUNE 25

PRODUCT BVS 5000i Bi-Ventricular Support System, intended for use as a mechanical circulatory support system
CODE Serial Numbers: 1693, 1697, 1701, 1716, 1722-1725.
MANUFACTURER Abiomed, Inc., Danvers, Massachusetts.
DISTRIBUTION California, District of Columbia, Florida, Pennsylvania, New York, Tennessee, Texas, Washington State.
QUANTITY 8 units were distributed.
REASON Solenoid valves do not provide adequate flow to the blood pump.

PRODUCT Seraflo Q-Set Hemodialysis Tubing Set (common name is "Q-set Bloodlines", Catalog numbers 205-Q01, 205-Q02, 205-Q03, 205-Q04, 205-Q05, 205-Q06, 205-Q07, 205-Q08, 205-Q09, 205-Q10, 205-Q11, 205-Q13 AND 205-Q14.
CODE All lot numbers and expiration dates.
MANUFACTURER Nissho Nipro Corporation, Sena, Ayuhaya, Thailand.
RECALLED BY Nipro Medical Corporation, Miami, Florida
DISTRIBUTION Nationwide and international.
QUANTITY 2,122,488 sets were distributed.
REASON The dialysis machines which utilize the Seraflo bloodlilnes may become contaminated with blood due to blood backing up in the bloodlines.

PRODUCT Shielded Trocar (obturator), Model: GT012, GT011, GT05, GT-05-7, GSNT11
CODE All 50 lots of 5 sizes of Trocars manufactured between 1/1/98 and 4/1/99
MANUFACTURER Gibbons Surgical Corporation, Virginia Beach, Virginia.
DISTRIBUTION Alabama, California, Pennsylvania, Texas, Michigan, Massachusetts, Missouri, Austria, Germany.
QUANTITY 51,080 units were distributed.
REASON Gamma sterilization was not validated. Devices were dosed at a different level than that provided for in validataion study.

PRODUCT Apex Universal Irrigation Console, pumps intended to provide necessary pressure ranges during arthroscopy from 20 to 150 mmHg. They also provide flow rates of up to 2000ml/min. for proper and safe joint distension and visualization: a) Model C7100; b) Model C7100A
CODE Models C7100 or C7100A Apex Irrigation Pumps with screened power supplies.
Serial Numbers: a) 1124, 1144, 1191, 1360, 1370, 1501, 1589, 1621, 1625, 1684, 1702, 1768, 1816, 1845, 1859, 2027, 2120
b) 1006, 1050, 1052, 1056, 1103, 1114. 1137, 1197, 1198, 1249, 1266, 1328, 1355, 1405, 1447, 1449, 1454, 1461, 1505, 1519, 1541, 1543, 1544, 1616, 1628, 1654, 1691, 1693, 1709, 1799, 1802, 1833, 1841, 1842, 1881, 1931, 1985, 2008, 2052, 2066, 2125, 10026, 10036, 10046, 10070, 10088, 10162, 10175, 10188, 10209, 10213, 10231,10256, 10262, 10263, 10342, 10381, 10384, 10387, 10414, 10418, 10429, 10434, 10436, 10438, 10445-10447, 10455, 10504, 10507, 10512, 10529, 10531, 10536, 10539, 10554, 10560, 10588, 10600, 10647, 10707, 10756, 10763, 10775, 10789, 10799, 10804, 10807, 10838, 10848, 10861, 10872, 10873, 10876, 10880, 10884, 10889, 10895, 10898, 10899, 10900, 10901, 10905-10907, 10909-10912, 10914-10916, 10918, 10919, 10922, 10925, 10927, 10928, 10930, 10933, 10938, 10939, 10941, 10943, 10944, 10949, 10951.
MANUFACTURER Linvatec Corporation, Largo, Florida.
DISTRIBUTION Nationwide and international.
QUANTITY 145 units were distributed.
REASON Pump may only operate intermittently.

PRODUCT IMMUNOCARD(TM) C. DIFFICILE, diagnostic test kit used for the detection of C. difficile Common Antigen.
CODE Lot Numbers: #706050.125 EXP 8/9/98; #706050.126, EXP 11/11/99. Product Number: 706050.
MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio.
DISTRIBUTION Nationwide, Italy, Canada.
QUANTITY A total of 304 kits (161 - lot #706050.125) and (143 - lot #706050.126).
REASON Negative color reactions may result in invalid or false negative test results.

PRODUCT Patil Emergency Cricothyrotomy Catheters:
a) Cook Citical Care Brand Patil Emergency Cricothyrotomy Catheter Set with 6 French Airway Catheter, Reorder No. C-DTJV- 6.0-6.0-PATIL;
b) Cook Critical Care Brand Patil Emergency Cricothyrotomy Catheter Set with 9 French Airway Catheter, Reorder No.C-DTJV-9.0-6.0-PATIL
CODE All Lot Numbers.
MANUFACTURER Cook Incorporated, Bloomington, Indiana.
DISTRIBUTION Nationwide and international.
QUANTITY 535 units were distributed.
REASON The 6 cc syringe will not connect to the cricothyrotomy catheter, thus not allowing aspiration to verify correct final placement of the catheter within the trachea as per the instructions for use.