Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Dressing Change Kit, DT15215, Sterile, Centurion Medical Products Corp., Williamston, MI. These kits are used for dressing changes.

FDA Recall Z-1470-2011 · Posted 2011-03-08

Recalling FirmCenturion Medical Products Corporation
Recall StatusTerminated
Product CodeMCY
Date Initiated2011-01-14
Date Terminated2011-06-21
Product Quantity68056 all kits

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.

Firm Action

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: [email protected]. 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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑