Z-0181-2010

Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with standard...

Name: Z-0181-2010 Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with standard...
Creator: Organogenesis, Inc.
Published: 2009-09-27
License: https://open.fda.gov/license/

Organogenesis, Inc. / initiated 2009-09-27 / Terminated / root cause: packaging

FDA source

Organogenesis, Inc. began a recall of Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with standard therapeutic compression for the treatment of... on 2009-09-27. The reason FDA records is "Unit contaminated with Staphylococcus epidermidis". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0181-2010
Status: Terminated
Initiated: 2009-09-27
Posted: 2009-11-12
Terminated: 2010-03-31
Recalling firm: Organogenesis, Inc.
Product: 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.
Product code: MGR Dressing, Wound And Burn, Interactive
Reason for recall: Unit contaminated with Staphylococcus epidermidis
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 60 units
Distribution: Nationwide Distribution
Product codes and lots: Lot: GS0909.01.01.1A, Expiration Date: October 8, 2009. Unit Numbers: 7-12, 16-50, 52-59, 61-66 and 68-73.

Product code MGR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)