Date Initiated by Firm | February 21, 2011 |
Date Posted | March 23, 2011 |
Recall Status1 |
Terminated 3 on July 28, 2011 |
Recall Number | Z-1747-2011 |
Recall Event ID |
58138 |
PMA Number | P950032 |
Product Classification |
burn and wound dressing - Product Code MGR
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Product | Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living, bilayered skin substitute |
Code Information |
Packaging Lot:: GS1101-13-.02.2A Unit Numbers: 3, 13, 25, 28, 46, 76, 128 Exp. Date 23 Feb 2011 |
Recalling Firm/ Manufacturer |
Organogenesis, Inc. 150 Dan Road Canton MA 02021-2820
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For Additional Information Contact | Patrick Bilbo 781-401-1155 |
Manufacturer Reason for Recall | Product sterility may be compromised |
FDA Determined Cause 2 | Packaging process control |
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. |
Quantity in Commerce | 7 units |
Distribution | Nationwide. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = MGR
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