Recall Notice: Fresenius Medical Care - CombiSet True Flow Series™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors

On January 14, 2011, Fresenius Medical Care North America announced a voluntary recall notice of CombiSet True Flow Series™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors (Part Numbers 03-2695-9 and 03-2795-7) for use with the Blood Volume Monitor (BVM), due to reports of arterial line kinks. These kinks may manifest as arterial pressure alarms or be mistaken as access problems. There is also the potential for kinking to cause hemolysis can result in serious injury or death. The recall includes the following part numbers and lot numbers which were sold in the U.S. and Canada.

Part Number: 03-2695-9
Lot Numbers: 10HR01065, 10HR01083, 10HR01197, 10HR01259, 10JR01019, 10JR01031, 10JR01040, 10JR01058, 10JR01067, 10JR01077, 10JR01239, 10LR01041, 10LR01053, 10LR01061, 10LR01070, 10LR01102,10LR01111, 10LR01123, 10LR01269, 10LR01282, 10LR01283, 10LR01284, 10LR01285, 10NR01020, 10NR01031, 10NR01041, 10NR01050, 10NR01146, 10NR01157, 10NR01169, 10NR01180

Part Number: 03-2795-7
Lot Numbers: 09JR01174, 09JR01229, 09NR01139, 10KR01801

Customers who have the affected lots of CombiSet True Flow Series™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for use with the BVM which are being recalled should discontinue their use immediately and return product to Fresenius Medical Care. Clinic Managers, Unit Administrators and/or distributors with questions may contact Fresenius Medical Care Customer Service Team at 1-800-323-5188 in USA (7am-6pm CST, 5 days per week, with after-hours emergency support) and 1-888-709-4411 in Canada.

In addition, it is advised that healthcare professionals and patients report any adverse health events related to use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting System. Click here for more information.

Recall Notice: Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination

On January 7, 2011, The Triad Group issued a recall involving all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad but sold as private labels at the consumer level. The recall pertains to all such products marked as either STERILE or non-sterile. The recall was initiated over concerns of possible product contamination with Bacillus cereus. Continued use of affected product could put at-risk patients at risk of developing life-threatening infections.
Recalled lots were distributed nationwide to retail pharmacies and sold in individual packets and in boxes containing 100 packets. The affected alcohol prep pads, alcohol swabs, and alcohol swabsticks can be identified by either "Triad Group," listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin. If a consumer has any of these types of products in their possession listing "Triad Group" as the manufacturer, they should not use the product and should return it to the place of purchase for a full refund. Click here for more information.

Recall Notice: AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform - Class I Recall

On January 5, 2011, AngioScore Inc. issued a recall of certain AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platforms manufactured by the company. The recall affects 17,682 units distributed from 09/2007 to 11/2010, including the following model part (REF) numbers and includes all sizes and lot codes for each model listed: 2076-4020, 2076-5020, 2076-6020, 2092-6020, 2105-6020. The devices are being recalled due to a design defect which can cause unintended fracture and peeling, resulting in fraying of the bond and/or detachment of the distal end of the scoring element. AngioScore Inc. is advising customer to immediately discontinue use of any recalled product. Not doing so may lead to retained device fragments or arterial injury that could lead to the need for surgical intervention or death. Click here for more information.

Recall Notice: American Regent Initiates Nationwide Voluntary Recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50mL Single Dose Vials

On December 23, 2010, American Regent issued a voluntary recall of its Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50 mL Single Dose Vials due to the possibility of vials containing particulate matter. If use is not discontinued, potential adverse health events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation. For this reason, American Regent is undertaking this recall in consideration of the potential for safety issues if any unapproved product is administered to patients. To access recalled product lot numbers, expiration dates, and additional instruction please, reference the Recall Notice in the following link.Click here for more information.