FDA Device

Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers and for the treatment of full-thickness neuropathic diabetic foot ulcers.

Hazard

Unit contaminated with Staphylococcus epidermidis

What You Should Do

Remedy

Organogenesis, Inc. initiated a recall notification dated September 28, 2009 via fax to Physicians asking for return of unused affected product. If the unit was used, Physicians are advised to use standard wound care precautions to assure the safety of the patient. Users were asked to acknowledge receipt by completing and returning the notification to the firm. For further information, contact Organogenesis, Inc. at 1-888-432-5232.

Products

Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcer
Brand
Organogenesis, Inc.
UPC
Lot: GS0909.01.01.1A, Expiration Date: October 8, 2009.  Unit Numbers: 7-12, 16-50, 52-59, 61-66 and 68-73.

Units Affected

60 units