SEPTEMBER 2000

WEEK ENDING SEPTEMBER 1

PRODUCT DMA Bilirubin Calibrator, in-vitro diagnostic used as a standard for in-vitro assays of serum total and direct bilirubin: a) Level 1, Catalog #241-151; b) Level 2, Catalog #241-152.
CODE a) Lot #RC22 EXP 10/30/00; b) Lot #RC96 EXP 08/30/00.
MANUFACTURER Data Medical Associates, Inc., Arlington, Texas.
DISTRIBUTION Kentucky, Ohio, Tennessee, Missouri, Florida, Louisiana, California, Mexico, Poland, Sri Lanka, India, Venezuela, Panama.
QUANTITY a) 327 vials; b) 131 vials were distributed.
REASON Some vials of product were producing out of range assay results.

WEEK ENDING SEPTEMBER 15

PRODUCT Troponin I Immunoassay, used in the quantitative determination of cardiac Troponin I in serum or heparinized plasma and as an aid in the diagnosis of acute myocardial infarction using the ACS:180 and ADVIA Centaur Automated Chemiluminescence System: ACS: 180 SYSTEMS AND ADVIA CENTAUR TROPONIN I Part # 110631 ACS:180 Troponin I 50T KitPart # 110632 ACS:180 Troponin I 300 KitPart # 116993 Advia Centaur Troponin I 100T KitPart # 116994 Advia Centaur Troponin I 500 T Kit.
CODE All lots.
MANUFACTURER Bayer Corporation, Medfield, Massachusetts.
DISTRIBUTION Nationwide, Switzerland, Sweden, the Netherlands, Australia, England, France, Belgium, Korea, Hong Kong, Canada, Greece, New Zealand, Italy, Africa, Poland, Germany.
QUANTITY Undetermined.
REASON Revised instruction for use due to false positive results.

PRODUCT IGT 135mm Wireless Probe, (a pointer), an accessory to Carl Zeiss' image guided surgery system.
CODE Part #:146210, Serial Numbers: 403092, 397894, 397933, 398039.
MANUFACTURER Image Guided Technologies, Inc., Boulder, Colorado.
RECALLED BY Carl Zeiss, Inc., Thornwood, New York
DISTRIBUTION Louisiana, Iowa, Canada.
QUANTITY 4 units were distributed
REASON Trajectory deviation of wireless probe. The line of sight trajectory for this pointer follows the angle of the bayonet, while the tracking system trajectory follows the line from the LED’s to the tip of the bayonet in a straight line.

PRODUCT Ultramix Mixing Bowl Single Mix CMW, Catalog #5401-59-000, intended for use in mixing bone cement.
CODE Lot #UE5AC4.
MANUFACTURER Depuy Orthopaedics, Inc., Warsaw, Indiana.
DISTRIBUTION England.
QUANTITY 120 bowls were distributed.
REASON There is a possible packaging anomaly that may allow for a non-sterile condition within the packaging or on the outside of the mixing bowl.

PRODUCT a) Precision Link Blood Glucose Data Management System Software Version 2.0 and 2.1; b) Precision Link Plus Data Management Software Version 1.0. The program extracts test results from glucose monitors and converts these results into charts, graphs, and reports. It provides information to monitor diet, exercise, and medication.
CODE a) Software Versions 2.0 and 2.1; b) Software Version 1.0.
MANUFACTURER Abbott Laboratories, Inc., Bedford, Massachusetts.
RECALLED BY Medisense, Inc., Bedford, Massachusetts
DISTRIBUTION Nationwide.
QUANTITY a) 16,179 units; b) 1,113 units were distributed.
REASON Glucose values greater than 600mg/dl are downloaded incorrectly.

PRODUCT Hewlett Packard (HP) M1465A Airway Adapter, accessory to carbon dioxide gas analyzer, intended to provide a breath-through gas sample cell for making CO2 concentration measurements as part of the HP CO2 monitoring systems for patients weighing more than 10 kg.
CODE HP lots with first four digits less than 4016.
MANUFACTURER Hewlett-Packard Company, Andover, Massachusetts.
RECALLED BY Agilent Technologies, Inc., Andover, Massachusetts
DISTRIBUTION Nationwide, Asia pacific, Canada, Latin America and Europe.
QUANTITY 70,000 units were distributed.
REASON Airway adapter out of dimensional specification which may result in air leak.

PRODUCT 1524, Tumisensor, all sizes, used for the diagnosis and treatment of erectile dysfunction.
CODE All units distributed after May 9, 2000.
MANUFACTURER Life-Tech Intl., Inc., Stafford, Texas.
DISTRIBUTION Utah and Minnesota.
QUANTITY 24 units were distributed.
REASON Product does not comply with performance standard: Electrode Lead Wires/Patient Cables, in that the connections are exposed.

PRODUCT Insyte AutoGuard IV Catheter, intravascular catheter to be inserted into the patient's vascular system for short term use to sample blood, monitor blood pressure, or administer fluids intravenously: Catalog No's. 381412, 381423, 381433, 381434, 381437, 381444, 381447, 381454, 381457, 381512, 381523, 381533, 381534, 381544 .
CODE Insyte AutoGuard IV Catheter,
Cat. No. 381412: Lots 909170, 910152, 910171, 911151, 911164, 912160 381423: Lots 909166, 909169, 909171, 909172, 909180, 909181, 910153, 910158, 910163, 910170, 910172, 910175, 910180, 910186, 911157, 911161, 911163, 912165, 911166, 911173, 911177, 912153, 912155, 912158, 912161, 912174, 912180, 912183, 001152, 001157, 001163, 001171.
Cat. No.381433: 909173, 910151, 910154, 911158, 912151, 912167.
Cat. No.381434: 907176, 907177, 908166, 908175, 908176, 909152, 909165, 910157, 910173, 910177, 910182, 911153, 911154, 911169, 911172, 911182, 911185, 912156, 912164, 912166, 912171, 912173, 912176, 912182, 001151, 001158, 001170.
Cat. No.381437: 911176
Cat. No.381444: 909178, 910155, 910162, 910164, 910174, 910176, 910179, 911156, 911159, 911165, 911178, 911180, 912152, 912159, 912162, 912169, 912177, 001153, 001159, 001164, 001172.
Cat. No.381447: 910169, 912172
Cat. No.381454: 910156
Cat. No.381457: 910167
Cat. No.381512: 910166, 910178, 911168, 911175, 912168.
Cat. No.381523: 908177, 910161, 910183, 911179, 912154, 912185, 001162.
Cat. No.381533: 910181, 911152, 912157.
Cat. No.381534: 908172, 909179, 910165, 911155, 911170, 912179, 001160.
Cat. No.381544: 910184, 911171, 912175.
MANUFACTURER Becton Dickinson Infusion Therapy Systems, Inc., Sandy, Utah.
DISTRIBUTION California, Delaware, Florida, Illinois, Indiana, Massachusetts, Michigan, Missouri, North Carolina, South Dakota, Tennessee, Texas, Washington state, West Virginia, Australia, Brazil, Canada, France, Italy, Japan, Mexico, Spain, United Kingdom.
QUANTITY 9,511,350 units were distributed.
REASON Localized skin irritation and infection at catheter insertion site.

PRODUCT SpO2 Extension Cables (Part Number 33 68 433 E53OU AND 33 75 834 E53OU) used with Siemens Patient Monitors: SC7000, SC8000, SC9000XL, and SC6002XL AND MIXED MONITORS-SC9000 or SC5000/6000 with SC7000, SC8000, SC900X, OR SC6002XL. Cables are connected to spO2 sensors and to either multimed or neomed pods are then connected to monitors.
CODE Siemens SpO2 Extension Cables (part numbers: 3368433E53OU-1 meter and 3375834e53OU- 2 meters) used with Siemens Infinity Patient Monitor Systems: SC9000XL, SC7000, SC8000, AND SC6002XL and mixed monitors SC9000 OR SC5000/6000 WITH SC7000, SC8000, SC900X, OR SC6002XL.
MANUFACTURER Siemens Medical Systems, Inc., Danvers, Massachusetts.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Older versions of the Sp02 Extension Cables may result in high Sp02 readings.

PRODUCT Strykeflow Suction Irrigator II, Model/Part #250-070-500,Intended for use in laparoscopic general surgery, laparoscopic gynecological surgery and nasal surgery.
CODE Serial Numbers: 00065832 and 0065812.
MANUFACTURER Stryker Puerto Rico, Arroyo, Puerto Rico.
RECALLED BY Stryker Endoscopy, Santa Clara, California
DISTRIBUTION Nationwide.
QUANTITY 1,452 units were distributed.
REASON Loss of sterility is possible.

PRODUCT Sandhill Scientific Schuster Anorectal Manometry Probe: a) Schuster Anorectal Probe (Adult);
b), Schuster Anorectal Probe (Pediatric).
CODE a) Catalog # A86-4050; b) Catalog # A86-5050.
MANUFACTURER Sandhill Scientific, Inc., Highlands Ranch, Colorado.
DISTRIBUTION California, Colorado, Georgia, Iowa, Indiana, Maryland, New Mexico, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington state, Switzerland.
QUANTITY 481 units were distributed.
REASON Labeling for internal and external balloons was reversed.

WEEK ENDING SEPTEMBER 22

PRODUCT Cleaning Brush (BW-9Y) for the Olympus SIF-Q140 Video Enteroscope, used for cleaning the endoscope's distal end when inserted through the suction channel (S-cylinder).
CODE Brush Part # BW-9Y.
Serial Numbers of SIF-Q140 enterescopes: 2900008, 2900009, 2900010, 2900011, 2900012, 2900013, 2900036, 2900040, 2900041, 2900042, 2900043, 2900044, 2900045, 2900046, 2900047, 2900048, 2900049, 2900053, 2900054, 2900055, 2900056, 2900057, 2900058, 2900059, 2900060, 2900061.
MANUFACTURER Olympus Opto-Electronics, Ltd. - Aizu Factory, Fukushima-Ken, Japan.
RECALLED BY Olympus America, Inc., Melville, New York
DISTRIBUTION Florida, Oregon, Pennsylvania, Louisiana, New York.
QUANTITY 5 units were distributed.
REASON Manufacturing defect - cleaning brush too short.

PRODUCT a) 6 French Disposable Angiographic Catheters; b) 6 French Special Catheters.
CODE Model Numbers: a) SPC-464D; SPC-464E, SPC 464F; b) SSD-694, SSD-790; SSD-937.
MANUFACTURER Millar Instruments, Inc., Houston, Texas.
DISTRIBUTION Nationwide, France, United Kingdom, Switzerland, Japan, Norway, Germany.
QUANTITY PC-464D: 1072 units, SPC-464E: 379 units, SPC-464F: 76 units, SSD-694: 3 units, SSD-937: 1 unit, SSD-790: 0 (none).
REASON Presence of small fibers that may shed during use. These catheters were used as components in the Millar devices.

PRODUCT Punctur-Gard Revolution Safety Needle Holder, used in conjunction with the Punctur-Guard Blood Collection Needle.
CODE Reorder Number: 4750
Lot Numbers: K0192, K1391, L2291, L2391, M0291, M0991, M1391, A0701,A2601, B0901, B2901, C1001, C1601, C2301, C2901, C3001, D1801. Shipping cases lot numbers: The number "4750" precedes the lot number, ex: "4750K0192"
MANUFACTURER Bio-Plexus, Vernon, Connecticut.
DISTRIBUTION Memphis and Tennessee.
QUANTITY 14,750 units were distributed.
REASON Holder may fail to activate needle safety mechanism.

PRODUCT Medtronic 6F SiteSeer Agiographic Catheter, used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessel.
CODE Catalog #6A0031, Lot #4533.
MANUFACTURER Medtronic AVE, Inc., Danvers, Massachusetts.
RECALLED BY Medtrtonics Interventional Vascular, Danvers, Massachusetts
DISTRIBUTION Germany, United Kingdom, Italy, China.
QUANTITY 320 units were distributed.
REASON Sterility of the device is compromised due to an improperly sealed pouch.

PRODUCT Testosterone Reagent Pack, 100 test units per pack, for in-vitro diagnostic use only, intended for the in-vitro quantitative measurement of testosterone in human serum and plasma.
CODE Lot #20 EXP 6/1/99.
MANUFACTURER Ortho-Clinical Diagnostics, Inc., Forest Farm Estate Whitchurch, Cardiff.
RECALLED BY Ortho-Clinical Diagnostics, Inc., Rochester, New York
DISTRIBUTION California, Florida, Indiana, Kentucky, Michigan, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Australia, Canada, Puerto Rico, Panama, Singapore, England, France, Germany, Italy, Spain.
QUANTITY 182 packs were distributed.
REASON Test results may be identified as ng/mL when results are for ng/dL.

PRODUCT Maxxum PTCA Dilation Catheters (Balloon Catheters) Catalog #H74914497300 (20 mm( and Catalog #H74914496300 (13mm), percutaneous transluminal coronary angioplasty catheters used to dilate coronary artery stenoses or previously placed stents.
CODE Lot # 2780769A, Catalog # H74914496300, expiration date: 2001-11; and Lot # 2781099A, Catalog # H74914497300, expiration date: 2001-11.
MANUFACTURER Boston Scientific Scimed, Inc., Maple Grove, Minnesota.
DISTRIBUTION Florida, Indiana, Oklahoma.
QUANTITY 8 catheters were distributed.
REASON Balloon PTCA Catheters were mislabeled as to length.

PRODUCT BE-148-4 Cuff Pressure Monitor.
CODE PO112599.
MANUFACTURER Instrumentation Industries, Inc., Bethel Park, Pennsylvania.
DISTRIBUTION California, Florida, Louisiana, Maryland, Minnesota, North Carolina, North Dakota, Ohio, Pennsylvania, Tennessee, Texas, West Virginia, Canada.
QUANTITY 103 units were distributed.
REASON There is a tight fit between small port and mating part (pilot line check valve) which precludes a connection.

PRODUCT Incubator 8000 NC/SC/IC (Neotatal Incubator) and Radiant Heater RH600 (Infant Radiant Heater). The heater was sold separately and could have been mounted to the incubator, floor stand or wall.
CODE Drager Incubator 8000 SC/NC/IC catalog numbers: FR00054, 2M21250, 2M21635, 2M21989, 2M220550, 2M21251, 2M21973, 2M220551, 2M21281, and 2M21966. Drager Radiant Heater RH600 catalog number: 2M20116.
MANUFACTURER Drager Medizintechnik GmbH (DMT) Lubeck, Germany.
RECALLED BY North American Drager, Telford, Pennsylvania
DISTRIBUTION Nationwide and Canada.
QUANTITY 487 units were distributed.
REASON The skin temperature sensor for the incubator 8000 is not working properly.

PRODUCT Radiolucent Threaded Cannula (5mm X 10mm), an endoscopic device that provides access to the patient's peritoneal cavity and allows insertion of endoscopic instruments and the removal of specimens.
CODE Catalog #MB319 and/or COE28.
MANUFACTURER Applied Medical Resources, Laguna Hills, California.
RECALLED BY Aesculap, Inc., South San Francisco, California
DISTRIBUTION Nationwide and Canada.
QUANTITY 68 units were distributed.
REASON The device has the potential to crack in the shaft of the cannula over time.

PRODUCT TSH Reagent Pack, Catalog #191 2997, intended for the in vitro quantitative measurement of thyroid stimulating hormone in human serum and plasma to aid in the differential diagnosis of thyroid disease.
CODE Lot #180 EXP 8/29/2000.
MANUFACTURER Ortho-Clinical Diagnostics, Inc., Forest Farm Estate Whitchurch Cardiff.
RECALLED BY Ortho-Clinical Diagnostics, Inc., Rochester, New York
DISTRIBUTION Alaska, Alabama, Florida, Indiana, Kentucky, North Dakota, Nebraska, Texas, Washington state.
QUANTITY 1,186 packs were distributed.
REASON Reagent instability caused negative bias with control and/or patient samples.

PRODUCT Tigertail Flexible Tip Ureteral Catheter labeled to contain 6 Fr. Catheters, used to facilitate urinary drainage from the kidney and/or injection of contrast media into the kidney.
CODE Lot # 07AK0326.
MANUFACTURER C.R. Bard, Inc., Queensbury, New York.
RECALLED BY C.R. Bard, Inc., Covington, Georgia
DISTRIBUTION Arizona, Colorado, Illinois, Missouri, New York, Utah, North Carolina, New Jersey.
QUANTITY 89 units were distributed.
REASON Package labeled as 6 FR. Catheters, contained 4 Fr. Catheters.

PRODUCT Utah Medical Products, Deltran IV-Plus Pressure Monitoring Kit, Catalog No. ABC-448-6.
CODE Lot #192335-1.
MANUFACTURER Utah Medical Products, Inc., Midvale, Utah.
DISTRIBUTION California, Michigan, Montana, West Virginia.
QUANTITY 185 units were distributed.
REASON Kits were mislabeled as an obstetric vacuum kit.

PRODUCT Abbott AxSYM Estradiol Reagent Pack, List 7A63-20, 10- test kit; an in-vitro diagnostic microparticle enzyme immunoassay (MEIA) for the quantitative determination of estradiol in human serum on the AxSYM System.
CODE All in date lots: 61221Q100, 61335Q100, 62242Q100, 62357Q100, 63162Q100, 64018Q100, 63259Q100.
MANUFACTURER Abbott Health Products, Inc., Barceloneta, Puerto Rico.
RECALLED BY Abbott Laboratories, Inc., Abbott Park, Illinois
DISTRIBUTION Nationwide, New Zealand, England, Australia, Dominican Republic, Mexico, Japan, Guatemala, Argentina, Singapore, Bermuda, Peru, Brazil, Korea, Hong Kong, Colombia, Taiwan, Canada, Thailand, Costa Rica, Chile, Pakistan, El Salvador, Curaco, Paraguay, India.
QUANTITY 13,675 kits were distributed.
REASON Depressed estradiol results when using the undiluted protocol.

PRODUCT IMx Estradiol Reagent Pack, List 2215-22, 100-test kit; an in-vitro diagnostic microparticle immunoassay (MEIA) for the quantitative determination of estradiol in human serum or plasma on the IMx Analyzer.
CODE Lot numbers 58417M300, 63210M100.
MANUFACTURER Abbott Laboratories, Inc., Abbott Park, Illinois.
DISTRIBUTION Nationwide, British West Indies, England, Australia, Dominican Republic, Mexico, Japan, Guatemala, Argentina, Singapore, Bermuda, Peru, Brazil, Korea, Hong Kong, Colombia, Taiwan, Canada, Thailand, Chile, Pakistan, Jamaica, Venezuela, Panama, Uruguay, Paraguay, West Indies, Antigua, Ecuador, Nicaragua, Turk and Caicos Islands, Bahamas, Honduras, Surinam, Germany, Italy, India.
QUANTITY 3,345 kits were distributed.
REASON Depressed estradiol results when using the undiluted protocol.

PRODUCT Vitros Immunodiagnostic - TSH Reagent Pack, 100 tests per pack, for the in vitro quantitative measurement of thyroid stimulating hormone in human serum and plasma.
CODE Lot number 340.
MANUFACTURER Ortho-Clinical Diagnostics, Inc., Forest Farm Estate Whitchurch Cardiff.
RECALLED BY Ortho-Clinical Diagnostics, Inc., Rochester, New York
DISTRIBUTION Nationwide, Canada, Australia, India, Japan, Singapore, England, France, Germany, Italy, Spain.
QUANTITY Domestic - 208 Packs (includes 10 to OCD); International 373 packs were distributed.
REASON Some TSH Reagent packs may contain incorrectly labeled reagent bottles.

PRODUCT Medtronic Sigma SDR303 and SS303 Implantable Pulse Generators, used for the restoration of heart rhythm.
CODE Serial numbers PJD622392S, PJD200335S, and PJD100767H,
MANUFACTURERS Medtronic Med Rel, Inc., Humacao, Puerto Rico. Switzerland Manufacturing Operations Tolochenaz, Switzerland.
RECALLED BY Medtronic, Inc., Minneapolis, Minnesota
DISTRIBUTION Puerto Rico, United Kingdom, and Germany.
QUANTITY 3 units were distributed.
REASON Final device programming does not match the label identification.

PRODUCT AcuMatch C-Series Cemented Femoral Component, Size 6 (Originally named the Exactech AuRa Hip System Femoral Component but has been renamed AcuMatch C-Series), hip implant, femoral component-these stems are intended to be used with bone cement for the treatment of skeletally mature individuals undergoing primary surgery for total hip replacement.
CODE Product #112-01-06, Serial Numbers: 0107189-0107208, 0112411-0112430, 0111635, 0121750-0121768, 0123858-0123861, 0143717-0143740.
MANUFACTURER Exactech, Inc., Gainesville, Florida.
DISTRIBUTION Florida, South Carolina, Alabama, New York, Louisiana, Pennsylvania, Minnesota, Ohio, New Jersey, Nebraska, Washington state, California, Connecticut, Michigan.
QUANTITY 43 units were distributed.
REASON Products were mislabeled with the incorrect stem length.

PRODUCT Datascope 9.5 Fr. 34 cc True Sheathless Intra-Aortic Balloon Catheter with 10 Fr. 6-inches Sheath, Model #0684-00-0314-01.
CODE Lot Numbers: AXD, AYL, ATS, ASC, AUD, AZI.
MANUFACTURER Datascope Corporation, Fairfield, New Jersey.
DISTRIBUTION Illinois, Michigan, Connecticut, California, Maryland, Arizona.
QUANTITY 169 units were distributed.
REASON The outside user label on the product describes the insertion kit as containing a 10 Fr. 11" catheter introducer instead of correctly identifying it as containing a 10 Fr. 6" catheter introducer.

PRODUCT Zimmer ZMR Hip System Implant Assembly Guide, Catalog #00-9975-043-00, used to record the orientation of the proximal body and distal stem implant provisionals for later assembly of the final implant components.
CODE Lot Numbers: 66806000, 66820900, 66915700, 68180600.
MANUFACTURER Zimmer, Inc., Warsaw, Indiana.
DISTRIBUTION Nationwide, Australia, Canada, Germany, Italy, Singapore and United Kingdom.
QUANTITY 177 units were distributed between March and June 2000.
REASON The product was found adulterated and misbranded, in that the alignment arrow was oriented incorrectly on the component.

WEEK ENDING SEPTEMBER 29

PRODUCT InnerDyne, Inc., One-Step Percutaneous Dilator with Sheath, intended to provide dilation access to the abdominal and thoracic cavities for performing diagnostic and opertative procedures.
CODE Part Number OS101012, Lot JD19293.
MANUFACTURER InnerDyne, Inc., Salt Lake City, Utah.
DISTRIBUTION Arizona, California, Florida, Illinois, Massachusetts, New York, Virginia, Wyoming.
QUANTITY 174 units were distributed.
REASON Compromised sterile barrier on the lid-stock of sealed product trays.

PRODUCT Otto Bock Modular Knee Joints, Model 3R36, used for lower limb amputees up to 220 pounds body weight, and with moderate activity levels.
CODE Batch 0150.
MANUFACTURER Otto Bock Orthopedische Industrie, Duderstadt, Germany.
RECALLED BY Otto Bock Orthopedic Industry, Inc., Minneapolis, Minnesota
DISTRIBUTION Nationwide and Germany.
QUANTITY 51 units were distributed.
REASON The prosthetic knee joint could fail due to setscrews, which can come loose.

PRODUCT Norian Pneumatic Mixer, used in conjunction with Norian Reactant Pack by automatically preparing Reactant Pack constituent components for transfer of mixed cement paste into sterile field.
a) Item #MXR-1000 Pneumatic Mixer Assembly
b) Item #MXR-PNE01-UNV Pneumatic Mixer Assembly
c) Item #5-MXR-1000 Pneumatic Mixer Assembly.
CODE All codes.
MANUFACTURER Norian Corporation, Cupertino, California.
DISTRIBUTION Nationwide.
QUANTITY 553 units were distributed.
REASON The sterility of the product may be compromised as evidenced by a loss of package integrity.

PRODUCT Allograft Heart Valve: a) Model No. AV10; b) Model No. PV00.
CODE Serial Numbers: a) 6815324; b) 6815701.
MANUFACTURER Cryolife, Inc., Kennesaw, Georgia.
DISTRIBUTION New York and Michigan.
QUANTITY 2 valves were distributed.
REASON Discordant serology results for Hepatitis B Core Antibody.

PRODUCT CryoValve Allograft, human heart valve replacement implant: a) Model No. AV05; b) Model No. PV05.
CODE Serial Numbers: a) 3997502; b) 3997529.
MANUFACTURER Cryolife, Inc., Kennesaw, Georgia.
DISTRIBUTION Texas.
QUANTITY 2 valves were distributed.
REASON Serodilution of plasma.

PRODUCT Customized Flextend(tm) Tracheostomy Tubes, with Standard Curve, wire reinforced distal shafts.
CODE All customized standard curve, wire reinforced distal shaft option tubes manufactured between January and July 2000 are under recall.The standard commercial FlexTend tracheostomy tubes, and other distal shaft options are not subject to this removal.
MANUFACTURER Bivona Medical Technologies, Gary, Indiana.
DISTRIBUTION Nationwide.
QUANTITY 132 units were distributed.
REASON The curved, wire-reinforced distal shaft fails to remain curved.

PRODUCT Dialysis Reverse Osmosis Water System, a single/stand alone water treatment system used in hemodialysis applications, designed to pre-treat and purify potable water for use in making dialysate for hemodialysis: Model Numbers: MROS, MRO1, and MRO2.
CODE Serial Numbers: 97095 to 97220.
MANUFACTURER Ameriwater, Dayton, Ohio.
DISTRIBUTION Ohio, Montana, Illinois, Colorado, Tennessee, Kentucky, Nebraska, Kansas, Virginia, Massachusetts, Oklahoma, New Jersey, Texas, Pennsylvania.
QUANTITY 58 devices were distributed.
REASON The RO system experiences a low draw-rate of peroxide/peroxyacetic acid (PAA) during sanitization of system.

PRODUCT Dr. Sweat’s Atlas Orthogonal Chiropractic Adjustment Table (also known as Atas Table), used to adjust the neck of chiropractic patients.
CODE Model number: WWO1100
Serial numbers: 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100118, 100119, 100120, 100121, 100122, 100123, 100124, 100125, 100126, 100127, 100128, 100129, 100130, 100131, 100132, 100133, 100134, 100135, 100136, 100138, 100139 and 100142.
MANUFACTURER Wuestec Medical, Inc., Mobile, Alabama.
RECALLED BY Sweat Chiropractic Clinic, Atlanta, Georgia
DISTRIBUTION Nationwide, Japan, Quebec and Hong Kong.
QUANTITY 32 units were distributed.
REASON Manufacturing defect could cause patient to be pinned by stylus to adjustment table.

PRODUCT CryoValve Allograft, heart valve.
CODE Serial Number 6802082.
MANUFACTURER Cryolife, Inc., Kennesaw, Georgia.
DISTRIBUTION Ohio.
QUANTITY 1 valve was distributed.
REASON Donor possessed adenocarcinoma of the prostate.

PRODUCT 33-mm CardioSeal Septal Occluder Implant (Sterile), designed to close intra-aortic defects percutaneously with the assistance of a Delivery System.
CODE Ref No. OCL-33-PFO Lot number: 0007403 Use Before: 2004-5.
MANUFACTURER Nitinol Medical Technologies, Inc., Boston, Massachusetts.
DISTRIBUTION Illinois and Virginia.
QUANTITY 4 units were distributed.
REASON Mislabeled as 33-mm vs 17-mm Septal Occluder Implant.

PRODUCT Angio-Seal Vascular Closure Device 6 French, Model 610091, for use in closing the femoral arterial puncture site in patients who have undergone diagnostic angiography procedures using a retrograde approach and a French or smaller procedural sheath
CODE Lot #22850.
MANUFACTURER Kensey Nash Corporation, Exton, Pennsylvania.
RECALLED BY St. Jude Medical, Inc., Daig Division, Minnetonka, Minnesota
DISTRIBUTION Nationwide.
QUANTITY 1,100 units were distributed.
REASON Device crimp stop can slip.

PRODUCT Immunocard H. Pylori, for the detection of IgG to Helicobacter pylori in human serum, plasma, or whole blood.
CODE Product Number: 710030 Lot Numbers #710030.093 EXP 2/20/02, #710030.095 EXP 3/8/01, #710030.096 EXP 3/8/01, and #710030.097 EXP 3/6/01.
MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio.
DISTRIBUTION Nationwide, Canada, Venezuela, New Zealand, Costa Rica, Philippines, Puerto Rico, Japan, Germany, and Italy.
QUANTITY 1,262 kits were distributed.
REASON The test ports of the cards may exhibit false negative results.

PRODUCT Stryker Rugged MX-Pro Ambulance Cots, a wheeled stretcher intended for EMS use: a) Model No. 6070; b) Model No. 6080.
CODE All cots manufactured between May 1998 to February 1999.
MANUFACTURER Stryker Medical, Kalamazoo, Michigan.
DISTRIBUTION United States, Bahrain, Canada, Chile, Mexico, Netherlands, Peru, South Africa, Switzerland, United Arab Emirates and United Kingdom.
QUANTITY 2,154 cots were distributed.
REASON The safety bar return springs located at the head end of the cots have failed.

PRODUCT Model Elite/Corium Laser System, various uses including dermatology, dentistry, ophthalmology, ENT, etc.
CODE None.
MANUFACTURER FISMA, Inc., Salt Lake City, Utah.
DISTRIBUTION Nationwide and international.
QUANTITY 239 units were distributed.
REASON Noncompliant calibration procedures in the operator's manuals.

CODE Catalog Numbers: a) ES0001, Lot FC b) ES0002, Lot FC.
MANUFACTURER Encision, Inc., Boulder, Colorado.
DISTRIBUTION California, Colorado, Georgia, Illinois, Louisiana, Maryland, Minnesota, Missouri, Mississippi, Oklahoma, Oregon, Texas, Washington state.
QUANTITY 49 units were distributed,
REASON Scissors inserts for electrosurgical instrument could come apart during use.