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Terminated

Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living, bi-layered skin substitute

FDA Recall Z-1746-2011 · Posted 2011-03-23

Recalling FirmOrganogenesis, Inc.
Recall StatusTerminated
Product CodeMGR
Date Initiated2011-01-30
Date Terminated2011-07-28
Product Quantity50 units

Reason for Recall

Product sterility compromised

Firm Action

Organogenesis notified accounts on Sunday, January 30, 2011, via fax and phone. The Company will collect written confirmation from the affected customers that they have been notified of the recall. Sales representatives for the affected customers have been directed to visit the customers as soon as possible Monday morning to assist in the recall and prevent additional applications of the product. Apligraf Medical Affairs personnel will provide clinical support to treating physicians, and update them as new information on microbial contamination and antibiotic susceptibility becomes available. Units not applied have been requested to be returned to Organogenesis

Root Cause

Material/Component Contamination

Distribution Pattern

nationwide.

Official Source

View FDA Recall →

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

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