December 27, 2002 - There are two recent dialysis-related product recalls in the FDA Enforcement Report for December 25, 2002:
PRODUCT: HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; Made in U.S.A.;
Recall # Z-0334-3/Z-0339-3. The following models are affected: a) Baxter HomeChoice Automated PD System, catalog 5C4471, 115 volt; b) Baxter HomeChoice Automated PD System, catalog 5C4474, 220 volt; c) Yume Automated PD System, catalog T5C4441, 100 volt; d) Baxter HomeChoice PRO Automated PD System, catalog 5C8310, 115 volt; e) Baxter HomeChoice PRO Automated PD System, catalog 5C8320, 220 volt; f) Yume Plus Automated PD System, catalog T5C8300, 100 volt.
CODE All HomeChoice and HomeChoice PRO Systems with software versions 8.51 and 8.52.
RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated September 19 and 20, 2002.
REASON: Blood leaks from the blood pump segment of the tubing set.
VOLUME OF PRODUCT IN COMMERCE: 53 units.
DISTRIBUTION: Internationally.
October 24, 2002 - There is one recent dialysis-related product recall in the FDA Enforcement Report for October 23, 2002:
PRODUCT: Baxter Syntra 120 & 160 Single Use Dialyzers; 24 dialyzers per case; a) catalog R5M6243: Syntra*120 - 1.2 square meters surfacearea. Recall # Z-0097-3; b) catalog R5M6246: Syntra*160 - 1.6 square meters surfacearea. Recall # Z-0098-3.
Class II recall - a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
CODE a) product code R5M6243, Model 120: lot numbers: (see FDA notice) b) product code R5M6246, Model 160: lot numbers: (see FDA notice).
RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated September 9, 2002. Manufacturer: Baxter Healthcare Corporation, Mountain Home, AR. Firm initiated recall is ongoing.
REASON Saline and blood leaks from the header.
VOLUME OF PRODUCT IN COMMERCE 119,964.
DISTRIBUTION CA, IN and Internationally.
August 22, 2002 - There is one recent dialysis-related product recall in the FDA Enforcement Report for August 21, 2002:
PRODUCT: Acid Concentrate for Bicarbonate Dialysate AC-2403-4 Manufactured For Gambro Use with Gambro BP-002 Bicarbonate products. One Gallon. Recall # Z-1220-2.
Class III recall - a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
CODE Lot G0G084.
RECALLING FIRM/MANUFACTURER Recalling Firm: Gambro Healthcare, Daytona Beach, FL, by telephone beginning on September 13, 2002. (???) Manufacturer: Di-Chem Concentrates, Inc., Lewisberry, PA. Firm initiated recall is complete.
REASON Incorrect expiration date of 4/00.
VOLUME OF PRODUCT IN COMMERCE 1,150 cases. DISTRIBUTION Nationwide.
August 15, 2002 - There are two recent dialysis-related product recalls in the FDA Enforcement Report for August 14, 2002:
PRODUCT: MedComp Custom Dialysis Trays/Kits.
The trays/kits are prep trays that do not contain a catheter. The trays/kits contain Wyeth's Heparin 1000 units/ml 1 ml dosette vial. Recall # Z-1197-2.
Class II recall - a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
RECALLING FIRM/MANUFACTURER Medical Components, Inc., Harleysville, PA, by letters May 6, 2002. Firm initiated recall is ongoing.
REASON Kits contain recalled Heparin.
VOLUME OF PRODUCT IN COMMERCE 8603 kits.
DISTRIBUTION Nationwide.
PRODUCT: Gambro Renal Products Acid Concentrate for Bicarbonate Dialysate AC-2412-4
Date of Mfg. DEC 01 EXP DATE: DEC 03. Recall # Z-1194-2.
Class III recall - a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
CODE Lot G1L034.
RECALLING FIRM/MANUFACTURER Recalling Firm: Gambro Renal Products, Daytona Beach, FL, by telephone and letter on December 21, 2001. Manufacturer: Di-Chem Concentrates, Inc., Lewisberry, PA. Firm initiated recall is complete.
REASON Incorrect ingredient concentrations on labeling.
VOLUME OF PRODUCT IN COMMERCE 41/ 4 gallon cases.
DISTRIBUTION VI, PA, MA and NYK.
July 22, 2002 - There are three recent dialysis-related product recalls in the FDA Enforcement Report for July 17, 2002:
PRODUCT: Fresenius brand Hemodialysis Delivery Systems, Model 2008K Software version 2.12. Recall # Z-1139-2. CODE Model 2008K. RECALLING FIRM/MANUFACTURER Recalling Firm: Fresenius Medical Care North America, Dialysis Product Division, Walnut Creek, CA, by telephone and letter on February 22, 2002. Firm initiated recall is ongoing. REASON Firm has received reports of excessive ultrafiltration. VOLUME OF PRODUCT IN COMMERCE 4,829 units. DISTRIBUTION Nationwide. Class II recall - a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. _______________________ PRODUCT Silicone Double Lumen Hemo Cath Kit. Each kit contains a Lidocaine HCl 1%, 5 cc ampule. Recall # Z-1140-2. CODE Catalog Number MCDLTSL28. Kit Lot number M929970 exp 5/02. RECALLING FIRM/MANUFACTURER Medical Components, Inc., Harleysville, PA, by letters on April 30, 2002. Firm initiated recall is ongoing. REASON Kit contains expired drug component. VOLUME OF PRODUCT IN COMMERCE 250 kits. DISTRIBUTION Nationwide. Class II recall - a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. _______________________ PRODUCT 16F Vascu Sheath and 17F Dilator. Recall # Z-1141-2/Z-1142-2. CODE The list below is Work Order Lot# (with the corresponding
catalog # in brackets) for the 16F Vascu Sheath: M207840 (ASPC28), M207850 (ASPC28), M207900 (ASPC24), M207940 (PD472S), M207950 (PDC621S), M207980 (TRAY #553), M208000 (TRAY #552), M208100 (TRAY #594), M208110 (ASPC32), M208120 (ASPC32), M208290 (ASPC28-XL), M208300 (ASPC28-XL), M208520 (ASPC28), M208580 (MCVS116S), M208630 (ASPC36-2), M208700 (ASPC32-XL), M209070 (PDC5652S), M209280 (ASPC24), M209290 (ASPC28), M209750 (ASPC28), M209890 (ASPC28), M209910 (ASPC32), M209920 (ASPC28), M210180 (ASPC28-XL), M210570 (ASPC55), M210880 (ASPC24-XL), M210930 (ASPC28-XL), M210990 (ASPC24), M211170 (ASPC28MP), M211330 (ASPC32), M211380 (TRAY #593), M211800 (TRAY #552), M211810 (TRAY #553), M211820 (ASPC36), M211840 (TRAY #553-XL), M212200 (TRAY #552), M212300 (ASPC32I), M212280 (ASPC28-2), M212290 (ASPC32-2), M212430 (TRAY #552), M212800 (ASPC32-XL), M213050 (ASPC24), M213060 (ASPC28), and M214290 (ASPC28). The list below is Work Order Lot # (with the corresponding catalog # in brackets) for the 17F Dialtor: M210580 (ASPC2816), M210820 (ASPC3216), M211770 (ASPC2416), M211790 (ASPC3216), and M212450 (ASPC2416). RECALLING FIRM/MANUFACTURER Medical Components, Inc., Harleysville, PA, by letter on April 30, 2002. Firm initiated recall is ongoing. REASON Reduced image contrast of dilator. VOLUME OF PRODUCT IN COMMERCE 8,917 units. DISTRIBUTION Nationwide and Canada. Class II recall - a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
April 25, 2002 - There are three recent dialysis-related product recalls in the FDA Enforcement Report for April 24, 2002:
Class II recall - a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
This is a disposable, single use kit used during dialysis.
CODE: Serial numbers 00041-44 thru 00050-77.
RECALLING FIRM/MANUFACTURER Recalling Firm: HemoTherapies, Inc., San Diego, CA, by issuing Returned Goods Authorizations beginning about October 27, 2001.
Manufacturer: HemoCleanse, Inc., Rochester, NY. Firm initiated recall is ongoing.
REASON: The filtrate generator was installed backwards, causing tension and crimping in the tubing line.
VOLUME OF PRODUCT IN COMMERCE: 13.
DISTRIBUTION: MN, NY and AZ.
PRODUCT: Liver Dialysis Unit Machine (LDU1) and Treatment Kits. Recall # Z-0878-2.
Class II recall - a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
CODE: All codes.
RECALLING FIRM/MANUFACTURER Recalling Firm: HemoTherapies, Inc., San Diego, CA, by letter dated June 22, 2001.
Manufacturer: UMM Electronics Inc., Indianapolis, IN. Firm initiated recall is ongoing.
REASON: Electronic controler board overheats causing alarm and device failure.
VOLUME OF PRODUCT IN COMMERCE: 21.
DISTRIBUTION: Nationwide.
PRODUCT: Liver Dialysis Unit Machines and kits. (aka LDU2) Product was previously named BioLogic DT System with BioLogic DT TK1000 kits. Recall # Z-0880-2.
Class II recall - a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
CODE: All units all codes.
RECALLING FIRM/MANUFACTURER Recalling Firm: HemoTherapies Inc., San Diego, CA, by letters dated June 22, 2001.
Manufacturer: UMM Electronics, Inc., Indianapolis, IN. Firm initiated recall is complete.
REASON: Units alarm and shut down for unexplained reason.
VOLUME OF PRODUCT IN COMMERCE: 6.
DISTRIBUTION: MA, IL and LA.
April 18, 2002 - There are two recent dialysis-related product recalls in the FDA Enforcement Report for April 17, 2002:
PRODUCT: Calcijex, Calcitriol Injection, For I.V. use,1 mcg/mL single dose ampul, Rx Only. Recall # D-230-2.
Class III recall - a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
CODE: Lot No. 85-305-DK, Exp Date May 1, 2003 NDC 0074-8110-31.
RECALLING FIRM/MANUFACTURER: Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letter on March 7, 2002. Manufacturer: Abott Laboratories, Rocky Mount, NC.
Firm initiated recall is ongoing.
REASON: Mispackaging: Vitamin K1 Injection found in a box of Calcijex injection.
VOLUME OF PRODUCT IN COMMERCE: 126,075 units.
DISTRIBUTION: Nationwide.
PRODUCT: PROSORBA Protein A Immunoadsorption Column - indicated for use in the therapeutic removal of immunoglobulin G (IgG) and IgG- containing circulating immune complexes from plasma in patients with idiopathic thromocytopenic purpura (ITP) having patelet counts less than 100,00mm3. The Prosorba column is indicated for use in the therapeutic reduction of the signs and symptoms of moderate to severe rheumatoid arthritis in adult patients with long standing disease who have failed or are intolerant to disease-modifying anti-rheumatic drugs (DMARDS). Recall # Z-0782-2.
Class II recall - a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
RECALLING FIRM/MANUFACTURER: Fresenius Hemocare, Inc., Redmond, WA, by letters dated September 20, 2001. Firm initiated recall is complete.
REASON: Increased potential to develop vasculitis.
VOLUME OF PRODUCT IN COMMERCE: 1737 columns distributed that are still within date.
DISTRIBUTION: Nationwide and Wendel and Hong Kong.
March 27, 2002 - There are two recent dialysis-related product recalls in the FDA Enforcement Report for March 27, 2002:
PRODUCT: Renasol Liquid Bicarbonate Concentrate BC-1-L Part B in one gallon (3.78 liter) bottles. Centrasol Liquid Bicarbonate Concentrate MB-330-L Part B in one gallon (3.78 liter) bottles. Recall # Z-0591-2.
Class III recall - a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
RECALLING FIRM/MANUFACTURER: Minntech Corp., Minneapolis, MN, by letter dated November 13, 2001. Firm initiated recall is ongoing.
REASON: Aureobasidium pullulans, a yeast that can form chains as a fungus, is in the recalled products.
VOLUME OF PRODUCT IN COMMERCE: 13365 cases (4 one-gallon bottles per case).
DISTRIBUTION: Nationwide.
PRODUCT: Renatron II, Renatron PA, and Renatron 100 Dialyzer Reprocessing System machines, and the Renaclear Dialyzer Cleaning system. Recall # Z-0629-2/0631-2.
Class III recall - a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
CODE: The serial numbers for the affected devices are identified below, following the device names. Renatron II Dialyzer Reprocessing System 14003, 14488, 14495, 14525, 14530, 14595, 14688, 14706, 14715, 14723 Renatron PA Dialyzer Reprocessing System PA1873, PA1879, PA1882 Renatron 100 Dialyzer Reprocessing System 14334, 14693,14695, 14696, 14699, 14700, 14717, 14720, 14721, 14724, 14739 Renaclear Dialyzer Cleaning System RC01125, RC01167.
RECALLING FIRM/MANUFACTURER: Minntech Corporation, Minneapolis, MN, by telephone beginning January 21, 2002. Firm initiated recall is ongoing.
REASON: The recalled devices have internal stainless steel valve components that may corrode.
VOLUME OF PRODUCT IN COMMERCE: 26 units.
DISTRIBUTION: Nationwide and Malaysia.
January 31, 2002 - There is one recent dialysis-related product recall in the FDA Enforcement Report for January 30, 2002:
RECALLING FIRM/MANUFACTURER Recalling Firm: Fresenius HemoCare, Inc., Redmond, WA, by telephone on Dec. 14, 2001.
Manufacturer: Fresenius HemoCare GmbH, The Netherlands. Firm initiated recall is ongoing.
REASON: Return line of tubing set smaller than normal.
VOLUME OF PRODUCT IN COMMERCE: 1905 sets.
DISTRIBUTION: Nationwide.
January 18, 2002 - There is one recent dialysis-related product recall in the FDA Enforcement Report for January 16, 2002:
PRODUCT Prisma Dialysis System Control Unit, Catalog No. 018080101, Serial Numbers 963111 thru 963143, and 963194 thru 963530, Recall # Z-0456-2. CODE Prisma Control Unit, Catalog No. 018080101, Serial numbers 963111 to 963143, 963194 to 963530. RECALLING FIRM/MANUFACTURER Recalling Firm: Gambro Renal Products Lakewood, CO, by letter on Oct. 2, 2001. Manufacturer: GAMBRO Dasco S.p.A. I-41036 Medolla (MO), IT Firm initiated recall is ongoing. REASON Displayed value of "actual patient fluid removal" can be incorrect VOLUME OF PRODUCT IN COMMERCE 161 DISTRIBUTION Nationwide.
December 21, 2001 - There is one recent dialysis-related product recall in the FDA Enforcement Report for December 19, 2001:
PRODUCT: Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL or Baxter Healthcare Corporation, McGaw Park, IL. Recall # Z-0362-02.
CODE: All System 1000 instruments are affected, and include the following serial number ranges, 1001S to 1142S, 50001 to 52109, and 01001 to 19250.
RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp. Round Lake, IL, by letter dated 11/12/01.
Manufacturer: Baxter/Althin Medical, Inc. Miami Lakes, FL. Firm-initiated recall ongoing.
REASON: Spontaneous Dialysate Proportioning Ratio change.
VOLUME OF PRODUCT IN COMMERCE: Approximately 20,500 units.
DISTRIBUTION Nationwide and International.
November 5, 2001 - There were two recent dialysis-related product recalls in the FDA Enforcement Report for October 24, 2001: (link is no longer available)
RECALL NUMBER, PRODUCT AND CODE: Z-0019-2/Z-0023-2, Nipro Safe Touch Safety Fistula Needle Codes: All model numbers and lot numbers are included in this recall.
REASON: Needle may separate from the hub of the fistula needle MANUFACTURER/RECALLING FIRM: Nissho Nipro Corp., LTD., Ayuthaya RECALLED BY: Nipro Medical Corporation Miami, FL, by telephone and letter on July 23, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: VA, IL, CO, TN and MA. QUANTITY: 696,500
RECALL NUMBER, PRODUCT AND CODE: Z-0067-2, NORMOCARB (Sterile Bicarbonate Renal Dialysis Concentrate). Lots: 1A530, 1A620, 1A940, 1B270, 1B280, 1C330, GA0951, GA1188, GA1190 and GA2889 Codes REASON: Contaminated with microorganism MANUFACTURER/RECALLING FIRM: Dialysis Solutions, Inc. Richmond Hills, Ontario, Canada RECALLED BY: Novex Pharma Richmond Hills, Ontario, Canada, FIRM INITIATED RECALL: Ongoing DISTRIBUTION: AL, CA, MA, MS, NY, NC, PA QUANTITY: Approx. 330 cases
[This message has been edited by Gary Peterson (edited 03-21-2003).]
