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Terminated

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.

FDA Recall Z-0181-2010 · Posted 2009-11-12

Recalling FirmOrganogenesis, Inc.
Recall StatusTerminated
Product CodeMGR
Date Initiated2009-09-27
Date Terminated2010-03-31
Product Quantity60 units

Reason for Recall

Unit contaminated with Staphylococcus epidermidis

Firm Action

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.

Root Cause

Packaging process control

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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