December 24, 2003 - There is one recent medical product recall of interest to the dialysis community in the FDA Enforcement Report for December 24, 2003:
PRODUCT: a) Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion. Reference: 8888-135192. Recall # Z-0233-04; b) Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion Reference: 8888-135195. Recall # Z-0234-04.
This is a Class III recall - a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
CODE a) Lot Number: 140885; b) Lot Number: 140774.
RECALLING FIRM/MANUFACTURER Kendall Healthcare Products Co, Mansfield, MA, by letter on December 1, 2003. Firm initiated recall is ongoing.
REASON Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5Fr x 16.0 cm.
VOLUME OF PRODUCT IN COMMERCE 55 catheters.
DISTRIBUTION IL, MA, OH, TN, TX, VA.
December 18, 2003 - There is one recent medical product recall of interest to the dialysis community in the FDA Enforcement Report for December 17, 2003:
PRODUCT: CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code 5M1736; 24 units per case. Recall # Z-0177-04.
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 Corp., Round Lake, IL, by letters dated October 30, 2003. Firm initiated recall is ongoing.
REASON Use of the dialyzers may cause iritis (red eye) patient reactions.
VOLUME OF PRODUCT IN COMMERCE 34,865 units.
DISTRIBUTION Nationwide, and Internationally.
October 28, 2003 - There is one recent medical product recall of interest to the dialysis community in the FDA Enforcement Report for October 29, 2003:
This is a 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 Number: 30956.
RECALLING FIRM/MANUFACTURER Vasca, Inc., Tewksbury, MA, by letter on September 22, 2003. Firm initiated recall is ongoing.
REASON Outer kit mislabeled with an extended expiration date.
VOLUME OF PRODUCT IN COMMERCE 81 units.
DISTRIBUTION Nationwide.
September 11, 2003 - There is one recent medical product recall of interest to the dialysis community in the FDA Enforcement Report for September 10, 2003:
PRODUCT: (Various) Baxter Solution Sets (see report)
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, Corp., Round Lake, IL, by letter dated July 16, 2003. Firm initiated recall is ongoing.
REASON There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
VOLUME OF PRODUCT IN COMMERCE 4,534,365 units.
DISTRIBUTION Nationwide and Internationally.
July 24, 2003 - There is two recent medical product recalls of interest to the dialysis community in the FDA Enforcement Report for July 23, 2003:
PRODUCT: Nipro SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula Set and EXEL Secure Touch Safety AV Fistula Needle Set. Recall # Z-0408-03.
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 catalog numbers and all lot numbers distributed between 10/24/2001 and 11/01/2002.
RECALLING FIRM/MANUFACTURER Nipro Corp, Miami, FL, by letter on November 8, 2002. Firm initiated recall is ongoing.
REASON Air or fluid leakage at the hub/needle junction.
VOLUME OF PRODUCT IN COMMERCE 6,984,000.
DISTRIBUTION Nationwide and Canada.
PRODUCT: Various IV adminstration sets and tubing. See the FDA Enforcement Report for a complete listing.
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 Abbott Laboratories HPD/ADD, Abbott Park, IL, by letters dated June 9, 2003, June 13, 2003, and July 7, 2003. Firm initiated recall is ongoing.
REASON The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
VOLUME OF PRODUCT IN COMMERCE 70,062,517 sets, 1,079,350 chambers.
DISTRIBUTION Nationwide and Internationally.
May 29, 2003 - There is one recent medical product recall of interest to the dialysis community in the FDA Enforcement Report for May 28, 2003:
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-0833-03.
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 1001S to 1142S; 50001 to 52109; 01001 to 23764.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, IL, by letters on March 20, 2003. Firm initiated recall is ongoing.
REASON The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.
VOLUME OF PRODUCT IN COMMERCE 25,014 units.
DISTRIBUTION Nationwide and Internationally.
May 28, 2003 - Baxter International Inc. last month received a warning from U.S. regulators for allegedly failing to meet quality control standards in the production of an intravenous tubing system, a letter released Tuesday said. Story from Reuters/Yahoo. (link is no longer available)
The FDA posted the letter to Baxter on its web site (pdf format).
May 8, 2003 - There is one recent medical product recall of interest to the dialysis community in the FDA Enforcement Report for May 7, 2003:
PRODUCT: a) Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 19 cm Arterial Cuff/22cm Venous Cuff Code #: 8888-219226. Recall # Z-0742-03; b) Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 23 cm Arterial Cuff/26cm Venous Cuff Code #: 8888-223266. Recall # Z-0743-03; c) Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 28 cm Arterial Cuff/31cm Venous Cuff Code #: 8888-228316. Recall # Z-0744-03; d) Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 19 cm Arterial Cuff/22cm Venous Cuff Code #:8888-219220. Recall # Z-0745-03; e) Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 23 cm Arterial Cuff/26 cm Venous Cuff Code #: 8888-223260. Recall # Z-0746-03; f) Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 28 cm Arterial Cuff/31cm Venous Cuff Code #:8888-228310 Recall # Z-0747-03.
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 codes.
RECALLING FIRM/MANUFACTURER Tyco Healthcare/Kendall, Mansfield, MA, by letter on March 20, 2003. Firm initiated recall is ongoing.
REASON Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter.
VOLUME OF PRODUCT IN COMMERCE 1,077 units.
DISTRIBUTION Nationwide and Internationally.
April 11, 2003 - There is one recent medical product recall of interest to the dialysis community in the FDA Enforcement Report for April 9, 2003:
PRODUCT
a) Baxter SPS 550 Single Patient System Hemodialysis Machine. Recall # Z-0660-03;
b) Baxter 1550 Single Patient System Hemodialysis Machines. Recall # Z-0661-03.
CODE
a) Catalog numbers: 5M1309, 5M1309R, 5M1310, 5M1310R, 5M5506, 5M5506R, 5M5507, 5M5507R, 5M5516, 5M5516R, 5M5518, 5M5518R, 5M5533, 5M5536, FM4649, FM4654, FM4714, FM4796R, FM4797; all serial numbers;
b) Catalog numbers: 5M5538, 5M5538R, 5M5551, 5M5551R, 5M5575, FM4719, FM4774, FM4779, FM4779R; all serial numbers.
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 Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated February 20, 2003. Manufacturer: Baxter Healthcare Corp., Deerfield, IL. Firm initiated recall is ongoing.
REASON Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (TMP).
VOLUME OF PRODUCT IN COMMERCE 17,322 units.
DISTRIBUTION Nationwide and Internationally.
March 13, 2003 - There is one recent medical product recall of interest to the dialysis community in the FDA Enforcement Report for March 12, 2003:
PRODUCT: Baxter Meridian Hemodialysis Instrument.
The instrument is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultra filtration controller to prevent excessive loss of water from the patient's blood, an extra corporeal blood set, and a high permeability dialyzer. The standard features of the Meridian instrument include a high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultra filtration control, standard and variable bicarbonate and sodium capabilities and automated chemical disinfection. The Meridian will operate in either the bicarbonate or acetate mode for concentrates. Recall # Z-0605-03.
This is a Class III recall - a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
CODE Product codes 5M5576, 5M5576R, serial numbers 200000 through 202864.
RECALLING FIRM/MANUFACTURER Baxter Healthcare, Corp., Round Lake, IL, by letter dated November 15, 2002. Firm initiated recall ongoing.
REASON Meridian hemodialysis instrument may reset when in shutdown mode causing the system to reset with potential for patient increased bioburden exposure.
VOLUME OF PRODUCT IN COMMERCE 2,864 units.
DISTRIBUTION Nationwide, Mexico, China, South Korea, Hong Kong.
March 6, 2003 - There is one recent medical product recall of interest to the dialysis community in the FDA Enforcement Report for March 5, 2003:
PRODUCTS:
HomeChoice Automated Peritoneal Dialysis Systems
; Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R. Recall # Z-0564-03;
REASON Potential for low ultrafiltrate volumes when using the Low Fill Mode during continuous cycling peritoneal dialysis (CCPD) therapy.
VOLUME OF PRODUCT IN COMMERCE 12,667 units.
DISTRIBUTION Nationwide and Internationally.
February 21, 2003 - There are two recent medical product recalls of interest to the dialysis community in the FDA Enforcement Report for February 19, 2003:
PRODUCT: Various Baxter solution administration sets
This is a Class I recall - a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
a) Baxter Vented Buretrol Volumetric Pump Solution Set, 10 drops/mL; catalog 1C8384; 10 units per case. Recall # Z-0504-03;
b) Baxter Interlink System Minivolume Extension Set;catalog 1C8412. Recall # Z-0505-03;
h) Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8516 and 1M8516Y. Recall # Z-0511-03;
i) Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8522 and 1M8522Y. Recall # Z-0512-03;
j) Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8527 and 1M85827Y. Recall # Z-0513-03;
k) Baxter Auto Syringe Extension Set with 0.22 Micron Filter, catalog 1M8529. Recall # Z-0514-03;
l) Baxter Minivolume T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2C5683, 48 units per case. Recall # Z-0515-03;
m) Baxter Minivolume Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2C5693, 48 units per case. Recall # Z-0516-03;
n) Baxter Interlink System Microbore T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3332, 200 units per case. Recall # Z-0517-03;
o) Baxter Interlink System Microbore T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3333, 200 units per case. Recall # Z-0518-03;
p) Baxter Microbore 3-Lead Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3342, 50 units per case. Recall # Z-0519-03;
PRODUCT: Lifepak 12 defibrillator/monitor - a portable battery operated, complete acute cardiac care response system with both manual and semi-automatic defibrillation operation. Recall # Z-0542-03.
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 LIFEPAK 12 units are affected.
RECALLING FIRM/MANUFACTURER Medtronic Physio Control Corp., Redmond, WA, by letter, on January 27, 2003. Firm initiated recall is ongoing.
REASON Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAk 12 unit.
VOLUME OF PRODUCT IN COMMERCE 46,042.
DISTRIBUTION Nationwide and Internationally.
[This message has been edited by Gary Peterson (edited 02-23-2004).]
