Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living, bilayered skin substitute
FDA Recall Z-1747-2011 · Posted 2011-03-23
Recalling FirmOrganogenesis, Inc.
Recall StatusTerminated
Product CodeMGR
Date Initiated2011-02-21
Date Terminated2011-07-28
Product Quantity7 units
Reason for Recall
Product sterility may be compromised
Firm Action
Organogenesis contacted the accounts by telephone and fax on 2/24/11 to advise of the contamination and identification fo the organism for appropriate patient follow-up.
Root Cause
Packaging process control
Distribution Pattern
Nationwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.