December 23, 2004 - There are threee medical device product recalls of interest to the dialysis community in the FDA Enforcement Report for December 22, 2004:
PRODUCT: Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Recall # Z-0299-05.
This is a 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 Serial numbers 200101 to 202190.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Renal Div., Mc Graw Park, IL, by letters dated December 2, 2004. Firm initiated recall is ongoing.
REASON The instrument power cord may become disconnected from the instrument and pose a fire or electrical shock hazard.
VOLUME OF PRODUCT IN COMMERCE 3,004 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT: Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange Device, 1.2 m (48inch); a sterile set consisting of a bag connector (spike connector) on-off clamp assembly, tubing and double scaling male Luer lock connector; product code R5C4325. Recall # Z-0301-05.
This is a 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 Lot H03L12057, expiration date 12/31/08.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Renal Div., Mc Graw Park, IL, by letter dated November 5, 2004. Firm initiated recall is ongoing.
REASON Disconnection of the tubing at the clamp level of the UV Flash Transfer Set.
VOLUME OF PRODUCT IN COMMERCE 1,152 sets.
DISTRIBUTION Internationally.
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; Recall # Z-0274-05.
This is a 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 system 1000 units with serial numbers prior to 22224.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Deerfield, IL, by letters on May 28, 2003. Firm initiated recall is ongoing.
REASON The air detector may not detect air bubbles consistently at the selected limit.
VOLUME OF PRODUCT IN COMMERCE 28,482 units.
DISTRIBUTION Nationwide and Internationally.
November 26, 2004 - There is one medical device product recall of interest to the dialysis community in the FDA Enforcement Report for November 24, 2004:
PRODUCT a) HomeChoice and Yume Automated Peritoneal Dialysis Systems; catalog numbers 5C4471, 5C4471R, T5C4441,T5C4441R. Recall # Z-0188-05; b) HomeChoice PRO and Yume Plus Automated Peritoneal Dialysis Systems; catalog numbers 5C8310, 5C8310R, T5C8300, T5C8300R. Recall # Z-0189-05.
This is a 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 that do not bear the CE marking.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Renal Div., McGaw Park, IL, by letters on November 1, and 2, 2004. Firm initiated recall is ongoing.
REASON The on/off power switch is not grounded as a separate component in the device, and can loosen from its housing, which may result in an electrical shock to the user.
VOLUME OF PRODUCT IN COMMERCE 23,00 units.
DISTRIBUTION Nationwide and Internationally.
October 21, 2004 - There is one medical device product recall of interest to the dialysis community in the FDA Enforcement Report for October 20, 2004:
PRODUCT Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8", Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034. Recall # Z-0017-05.
This is a 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 Lot Numbers: 3LR240, 3NR190, 3SR074, 4AR119, 4BR187, 4CR290.
RECALLING FIRM/MANUFACTURER Fresenius Medical Care North America, Lexington, MA, by telephone starting September 20, 2004, and by letter on September 27, 2004. Firm initiated recall is ongoing.
REASON Peritoneal Dialysis Transfer Set may have occluded pathway.
VOLUME OF PRODUCT IN COMMERCE 3,510 units.
DISTRIBUTION Nationwide and Canada.
October 14, 2004 - There is one medical device product recall of interest to the dialysis community in the FDA Enforcement Report for October 13, 2004:
PRODUCT Ameriwater Portable RO+, model numbers MR01 and MR02. The device is reverse osmosis system for dialysis. Recall # Z-0004-05.
This is a 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 Ameriwater Inc., Dayton, OH, by letter on September 3, 2004. Firm initiated recall is ongoing.
REASON The device has a potential risk of failure caused by faulty wiring within the electrical component. The wires can overheat and eventually break in two.
VOLUME OF PRODUCT IN COMMERCE 148 units.
DISTRIBUTION Nationwide.
August 26, 2004 - There is one medical device product recall of interest to the dialysis community in the FDA Enforcement Report for August 25, 2004:
PRODUCT: Accura System for Blood Filtration, a) product codes 5M5660 and b) ACCURA01 (international); a hemofiltration system. Recall # Z-1338-04.
This is a 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 Baxter Healthcare Renal Div., Mc Gaw Park, IL, by letter dated July 26, 2004. Firm initiated recall is ongoing.
REASON The Accura machine display screen may go blank during patient treatment. There is a potential risk to the patient in that the operator may try to manipulate the controls in response to a blank screen, which could affect the current patient�s treatment.
VOLUME OF PRODUCT IN COMMERCE 85 units.
DISTRIBUTION Nationwide and Internationally.
July 17, 2004 - There is one medical device product recall of interest to the dialysis community in the FDA Enforcement Report for July 14, 2004:
PRODUCT: a) NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-124, 6 units per case. Recall # Z-1069-04; b) NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-153 Cartridge Express. 6 units per case. Recall # Z-1070-04; c) NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model # CAR-154 Cartridge Express, 6 units per case. Recall # Z-1071-04.
Class III recall: A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
CODE a) Lot Numbers from and including FG-031216-01 to FG-040322-01; b) Lot Numbers from and including FG-031216-01 to FG-040322-01; c) Lot Numbers from and including FG-031216-01 to FG-040322-01.
RECALLING FIRM/MANUFACTURER NxStage Medical, Inc., Lawrence, MA, by recall notice dated April 14, 2004. Firm initiated recall is ongoing.
REASON Pinhole leaks on the replacement (RF) side FMP bag in certain lots of its disposable cartridge balance chambers resulting in loss of dialysate or ultrafiltrate.
VOLUME OF PRODUCT IN COMMERCE 1,188 units.
DISTRIBUTION CA, IL, IN, MD, IA, MO, NJ, OH, and VT.
June 24, 2004 - There is one medical device product recall of interest to the dialysis community in the FDA Enforcement Report for June 23, 2004:
PRODUCT a) Circle C� Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm, Sterile. The product is a clear rigid plastic surgical tray containing components required for implantation. Components of the inner tray are in a separate sterile pouch. The tray and components are then sealed in an outer clear plastic pouch. Catalog #DLC600-64C. Recall # Z-1029-04;
b) Circle C� Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, DCL-800TEC 12 Fr. x 20.3cm. The product is a clear rigid plastic surgical tray containing components required for implantation. Components of the inner tray are in a separate sterile pouch. The tray and components are then sealed in an outer clear plastic pouch. Recall # Z-1030-04.
CODE a) Lot Numbers 335418 and 356778; b) Lot Numbers 3538781, 356779 & 342251.
RECALLING FIRM/MANUFACTURER Horizon Medical Products, Inc., Manchester, GA, by letter on May 28, 2004. Firm initiated recall is ongoing.
REASON The products have a potential defective seal that closes the product�s OUTER POUCH. The surface of the INNER TRAY may no longer be sterile.
VOLUME OF PRODUCT IN COMMERCE 621 Units.
DISTRIBUTION Nationwide.
June 17, 2004 - There is one medical device product recall of interest to the dialysis community in the FDA Enforcement Report for June 16, 2004:
PRODUCTS: a) HomeChoice and Yume Automated Peritoneal Dialysis Systems; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R. Recall # Z-1012-04; b) HomeChoice PRO and Yume PlusAutomated Peritoneal Dialysis Systems; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R. Recall # Z-1013-04.
This is a 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) and b) All HomeChoice Systems with software versions 8.5 and higher.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Renal Div, Mc Gaw Park, IL, by letters dated May 24, 2004. Firm initiated recall is ongoing.
REASON A software defect could result in a patient experiencing an overfill with software versions 8.5 and higher. The possibility of an overfill can occur when the Initial Drain Alarm Volume is set to OFF and a change to the volume is made at the Verify I-DRAIN:XXXXML prompt.
VOLUME OF PRODUCT IN COMMERCE 17,026 units.
DISTRIBUTION Nationwide and Internationally.
May 20, 2004 - There is one medical device product recall of interest to the dialysis community in the FDA Enforcement Report for May 19, 2004:
PRODUCT: a) Baxter Renal Software Suite (Renal Link and PD Link). Recall # Z-0901-04; b) Renalsoft software system. Recall # Z-0902-04.
This is a 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 codes 5M5590, 5M5591, 5M5592, 5M5593, 5M5594, 5M5595, 5M5596, 5M5603, 5M5604, R5C4532, R5C4534, 5M5597, 5M5541, 5M5541R, all software versions; b) Product code RENLSFT, all software versions.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Renal Div., McGaw Park, IL, by letters dated April 12, 2004. Firm initiated recall is ongoing.
REASON There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.
VOLUME OF PRODUCT IN COMMERCE 4,164 units.
DISTRIBUTION Nationwide.
April 16, 2004 - There is one medical device product recall of interest to the dialysis community in the FDA Enforcement Report for April 14, 2004:
PRODUCT: a) BD Test Strips. The US market BD Test Strips are identified by Catalog Numbers 322027 (50 count BD Test Strips Durable medical Equipment consignees), 322053 (50 Count BD Test Strips Trade consignees), and 322060 (10 Count BD Test Strips packaged within BGM kits). The Canadian market BD Test Strips are identified by Catalog Numbers 322002 (50 count BD Test Strips), 322003 (100 count BD Test strips), and 322009 (10 count BD Test strips). Health Hazard Evaluation: There is negligible medical risk to patients with diabetes using the BD blood glucose systems due to the increase of E-3 error messages. Recall # Z-0763-04;
b) The BD Blood Glucose Monitoring Systems identified as the BD Latitude, and BD Logic. Becton Dickinson also distributes the Paradigm Link Blood glucose Monitor which is sold exclusively for Medtronic Mini Med. US Market BD Blood Glucose Monitoring System kit catalog Numbers: 322025 (BD Logic Blood Glucose Monitor Durable Medical Equipment consignees); 322050 (BD Latitude Diabetes Management System); 322051 (BD Logic Blood Glucose Monitor); 32205175 ( BD Logic Blood Glucose Monitor); 322200 (Paradigm Link Blood Glucose Monitor - clear); 322201 ( Paradigm Link Blood Glucose Monitor - smoke); 322202 (Paradigm Link Blood Glucose Monitor - blue); 322203 (Paradigm Link Blood Glucose Monitor - purple). Canadian market BD Blood Glucose Monitoring System kit catalog numbers: 322000 (BD Latitude Diabetes Management System); 322001 (BD Logic Blood Glucose Monitor). Recall # Z-0764-04.
This is a 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
(See FDA Enforcement report for complete list.)
RECALLING FIRM/MANUFACTURER Becton Dickinson & Company, Franklin Lakes, NJ, by letters dated January 29, 2004. Firm initiated recall is ongoing.
REASON 39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing.
VOLUME OF PRODUCT IN COMMERCE a) 15,011,221; b) 207,092.
DISTRIBUTION Nationwide and Canada.
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April 12, 2004 - Here is a clarification from Asahi Medical on the mention of their APS-S series dialyzers in the April 7, 2004 FDA Enforcement Report :
Dear Customer,
Asahi Medical has learned from an article in RenalWEB that APS-S series was specified as recall products, referring to the recent issue of the FDA Enforcement Report.
During the FDA Inspection of our company this year in January, it was suggested that our past field corrective action in 2001 to the beginning of 2002 for APS-S leakage problem might be considered a type of recall. In accordance with that suggestion, Asahi retrospectively submitted the relevant report to FDA and then they updated the Enforcement Report as their formal action. Thus, FDA mentions on their Enforcement Report that our initial action was completed. We also received a letter from FDA on this matter, which states:
"Information provided to the FDA indicates that the recall has been completed and there has been proper disposition of the recalled articles. Therefore, FDA considers the recall terminated."
Recall cited in the article on RenalWEB is concerning the past products and not the products currently sold in the market. Therefore, please note that a removal of any Asahi products from customer is not required.
We thank you for your understanding and your input is very valuable in our effort to continuously improve the quality of our products and services. Please contact Karen Borling or Mike Jackson at U.S. Representative Office at 847-498-8500 should you have any further question.
Sincerely,
Seiichi Iijima General Manager, Regulatory Affairs Asahi Medical Co., Ltd
April 9, 2004 - There are two medical device product recalls of interest to the dialysis community in the FDA Enforcement Report for April 7, 2004:
PRODUCT: Asahi APS Series Dialyzers, Model Nos. APS-100S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S. The dialyzers are intended for single or initial use and under reprocessing and reuse conditions for up to 15 reuse cycles. Recall # Z-0739-04.
CODE The recall is no lot specific.
RECALLING FIRM/MANUFACTURER Asahi Medical Co., Ltd, Chiyoda Ku, JP, by visit starting on October 1, 2001. Firm initiated recall is complete.
REASON Customer reprocessing methods for the reusable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis.
VOLUME OF PRODUCT IN COMMERCE 180,000 units estimated.
DISTRIBUTION NJ, OH, TX, CA, GA, PA, IL, and IN.
PRODUCT: Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R. Recall # Z-0758-04.
CODE All serial numbers.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Renal Div., Mc Gaw Park, IL, by letters dated March 11, 2004. Firm initiated recall is ongoing.
REASON Microbubbles of air in the extracorporeal blood circuit during hemodialysis therapy on the Meridian.
VOLUME OF PRODUCT IN COMMERCE 2,949 units.
DISTRIBUTION Nationwide, Mexico, China and Korea.
March 25, 2004 - There is one medical device product recall of interest to the dialysis community in the FDA Enforcement Report for March 24, 2004:
PRODUCT: Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue Flex Tip Arrowgard Blue Curved Catheter for high Volume Infusions. Recall # Z-0639-04.
This is a 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 Product number AK-22142-CF Lot numbers RF2035008, RF2067620, RF2100365, RF3023691, RF3045916, RF3078012, RF3089042, RF3099786, RF3121691, and RF3122085. Product number AK-22142-CFSP Lot numbers RF2046619, RF2046669, RF3099895, and RF3111053. Product number AK-22142-F Lot numbers RF1105891, RF2100885, RF3088793, RF3089028, RF3089202, RF3099359, RF3100354, RF4012646. Product number AK-25142-CF Lot number RF1080802, RF1094019, RF2010218, RF2067624, RF2100633, RF2100886, RF3067453, RF3088794, RF3099633, RF3100446, and RF3121805. Product number AK-25142-CFSP Lot numbers RF2010219, RF2046670, RF3100573, and RF3111264. Product number AK-25142-F Lot numbers RF1104566, RF3024351, RF3034977, RF3056501, RF3088861, RF3089029, RF3099313, and RF3100355. Product number CS-22142-CF Lot numbers RF1028262, RF1033063, RF1105890, RF2099516, RF2111093, RF3013358, RF3077978, RF3088513, RF3099272, and RF3100452. Product number CS-22142-F Lot numbers RF1033064, RF2100484, RF3045575, RF3088456, and RF3051547. Product number CS-25142-CF Lot numbers RF1082563, RF1104918, RF1105889, RF2089343, RF2100890, RF2111125, RF3056376, RF3067264, and RF3099410. Product number CS-25142-F Lot numbers RF1104919, RF2111094, RF2111192, RF2111673, RF3023765, RF3035176, RF3045410, RF3056617, RF3099369, RF3121572, and RF4012292.Product number CS-26142-F Lot numbers RF2111134, RF2111290, RF3078240, RF3088795, RF3099586, RF3100056, RF3100272, RF3111001, RF3111434, and RF3121623.
RECALLING FIRM/MANUFACTURER Arrow International, Inc., Reading, PA, by letter dated February 18, 2004. Firm initiated recall is ongoing.
REASON Catheter slips out of the suture wing during use.
VOLUME OF PRODUCT IN COMMERCE 6,610 units.
DISTRIBUTION Nationwide and Internationally.
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March 11, 2004 - There is one medical device product recall of interest to the dialysis community in the FDA Enforcement Report for March 10, 2004:
PRODUCT: a) Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000. Recall # Z-0583-04; b) Baxter Arena Hemodialysis Delivery System. Recall # Z-0584-04.
This is a 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) Serial numbers 1001S to 1142S; 50001 to 52109; 01001 to 26231; b) Serial numbers 300001 through 300147.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Renal Div., McGaw Park, IL, by letters dated February 20, 2004. Firm initiated recall is ongoing.
REASON These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in a fire.
VOLUME OF PRODUCT IN COMMERCE 28,435 units.
DISTRIBUTION Nationwide and Internationally.
January 22, 2004 - There are two recent medical product recalls of interest to the dialysis community in the FDA Enforcement Report for January 21, 2004:
PRODUCT: a) Baxter HomeChoice Automated PD Set with Lineo Connector, 4-prong, product codes R5C4479Q (English) and N5C4479Q (dual English/French label); 30 units per case. Recall # Z-0340-04; b) Baxter Lineo Opticap Disconnect Cap, product codes R5C4599Q (English) and N5C4599Q (dual English/French label); 30 units per case. Recall # Z-0341-04.
This is a 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 R5C4479Q, lots H03J01492, H03J17027 and H03J24056 and product code N5C4479Q, lots H03I10114, H03I12078, H03J05030 and H03J15088. b) Product code R5C4599Q, lots H03J02029 and H03J27067 and product code N5C4599Q, lots H03I18083, H03I23018 and H03J29022.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, IL, by letters dated December 5, 2003 and December 8, 2003. Firm initiated recall is ongoing.
REASON Reports of loosening of the connections and disconnection of the device.
VOLUME OF PRODUCT IN COMMERCE 14,950 units.
DISTRIBUTION Canada and the United Kingdom.
PRODUCT a) Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H. Recall # Z-0349-04; b) Hollow Fiber Dialyzer Model FILTRYZER B3-1.0A, B3 -1.3A, and B3-1.6a. Recall # Z-0350-04; c) Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU. Recall # Z-0351-04; d) Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8. Recall #Z-0352-04.
This is a 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) Lot 10830640 (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual units or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04 or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.); b) Lot numbers: 10630840, 10230940, and 20230540. (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual units or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04 or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.); c) Lot numbers 10531140, 11230940, 20121440, and 21230140. (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual units or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04 or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.); d) Lot numbers: 20310140, 20910540, and 20910541. (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual unit or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04 or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.).
RECALLING FIRM/MANUFACTURER Toray Marketing & Sales (America), Inc., Houston, TX, by telephone and letter on January 2, 2004 and January 5, 2004. Firm initiated recall is ongoing.
REASON Potential loose header (end cap) on hollow fiber dialyzers.
