Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021
FDA device recall Z-0675-2008 · posted 2008-01-24 · Terminated
Recall details
- Recalling firm
- Organogenesis, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- MGR
- Quantity affected
- 177 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2007-12-26
- Date posted
- 2008-01-24
- Date terminated
- 2015-05-15
- Location
- Canton, MA
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