Dressing Change Tray for CVC & PICC Lines, DT12105, Sterile, Centurion Medical Products Corp., Williamston, MI. These ki

FDA device recall Z-1462-2011 · posted 2011-03-08 · Terminated

Recall details

Recalling firm

Centurion Medical Products Corporation

Reason for recall

The firm is conducting a subrecall of kits containing Triad Groups alcohol prep pads. Triad initiated a recall of prep pads due to a concern about potential contamination of the products with an objectional orgainism, Bacillus cereus.

Action taken

The firm, Centurion Medical Products, sent an "URGENT PRODUCT RECALL NOTICE" dated January 12, 2011 to affected customers via Certified Mail, Return Receipt Requested. The notice described the product, problem and action to be taken. The customers were instructed to identify and remove all inventory of the recalled kits in their possession; forward a copy of this notice to any customers that this product was further distributed to, and complete and return the attached Accountability Record form via fax to 517-546-3356 or email to: lcarpenter@centurionmp.com. The notice states that a Centurion representative will contact them regarding retrieval of the product from the facility. Should your require additional information, please contact the Director of Quality Assurance & Regulatory Affairs at (517) 546-5400 ext. 1135.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MCY

Quantity affected

68056 all kits

Distribution

Nationwide distribution: USA including state of: CT, ID, NM, MA, MO, MT, VA and SC.

Date initiated

2011-01-14

Date posted

2011-03-08

Date terminated

2011-06-21

Location

Williamston, MI