FDA Device

Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021

Hazard

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.

What You Should Do

Remedy

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.

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Products

Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021
Brand
Organogenesis, Inc.
UPC
Lot Numbers: GS0711.20.01.2A and GS0711.22.01.2A

Units Affected

177 units

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