Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living, bi-layered skin substitute
Hazard
Product sterility compromised
What You Should Do
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
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Products
- Brand
- Organogenesis, Inc.
- UPC
- 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
Units Affected
50 units