—#97366

Product

Dressing Change Tray for Hickman & Dialysis Catheters, DT12110, Sterile, Centurion Medical Products Corp., Williamston, MI. These kits are used for dressing changes.

FDA product code: MCY — Wound Dressing Kit
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: 2010031590, 2010122090, 2010012590.

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Centurion Medical Products Corporation
Address: 100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

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

Timeline

Recall initiated: 2011-01-14
Posted by FDA: 2011-03-08
Terminated: 2011-06-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97366. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.