Date Initiated by Firm | December 26, 2007 |
Date Posted | January 24, 2008 |
Recall Status1 |
Terminated 3 on May 15, 2015 |
Recall Number | Z-0675-2008 |
Recall Event ID |
46250 |
PMA Number | P950032 |
Product Classification |
Wound Dressing - Product Code MGR
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Product | Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021 |
Code Information |
Lot Numbers: GS0711.20.01.2A and GS0711.22.01.2A |
Recalling Firm/ Manufacturer |
Organogenesis, Inc. 150 Dan Road Canton MA 02021-2820
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For Additional Information Contact | Patrick Bilbo 781-575-0775 |
Manufacturer Reason for Recall | Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis. Preliminary tests show a gram negative rod (bacillus) organism. |
FDA Determined Cause 2 | Material/Component Contamination |
Action | On 12/26/07, Organogenesis began to telephone the consignees to inform them of the recall. The firm sent a follow-up fax on 12/31/07 to all treating physicians who applied the product requesting patient status information. The Dear Doctor letter, dated December 27, 2007, was titled, "Subject: Potential contaminated Apligraf Units manufactured by Organogenesis, Inc." Consignees were instructed to return unused product, and monitor patients who received the Apligraf for adverse events. |
Quantity in Commerce | 177 units |
Distribution | Nationwide Distribution. |
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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