Recall Z-1746-2011
Organogenesis, Inc. · initiated January 30, 2011
Product
Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living, bi-layered skin substitute
Codes / lots: Lot Number GS1012.28.05.2A Unit Numbers: 2, 5, 6, 7,8, 9,10, 11, 12, 13, 14, 15,16, 17,18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 29, 31, 32, 34, 36, 37, 38, 39, 40, 41, 42,43, 44, 45,46, 50,51, 52, 53, 55, 56, 69 ,135, 200
Reason for recall
Product sterility compromised
FDA-determined cause: Material/Component Contamination
Action taken
Organogenesis notified accounts on Sunday, January 30, 2011, via fax and phone. The Company will collect written confirmation from the affected customers that they have been notified of the recall. Sales representatives for the affected customers have been directed to visit the customers as soon as possible Monday morning to assist in the recall and prevent additional applications of the product. Apligraf Medical Affairs personnel will provide clinical support to treating physicians, and update them as new information on microbial contamination and antibiotic susceptibility becomes available. Units not applied have been requested to be returned to Organogenesis
Details
- Recall number
- Z-1746-2011
- Initiated
- January 30, 2011
- Posted by FDA
- March 23, 2011
- Terminated
- July 28, 2011
- Product code
- MGR – Dressing, Wound And Burn, Interactive
- Quantity
- 50 units
- Distribution
- nationwide.
- Recalling firm
- Organogenesis, Inc., Canton, MA