Device Recall Dressing Change Tray for Hickman & Dialysis Catheters 의 리콜

Recall

57767

Class 1

Z-1463-2011

2011-01-14

2011-03-08

Terminated

United States

2011-06-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97366

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.

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.