Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with standard therapeutic compr
FDA device recall Z-0181-2010 · posted 2009-11-12 · Terminated
Recall details
- Recalling firm
- Organogenesis, Inc.
- Reason for recall
- Unit contaminated with Staphylococcus epidermidis
- Action taken
- 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
- Status
- Terminated
- Product code
- MGR
- Quantity affected
- 60 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-09-27
- Date posted
- 2009-11-12
- Date terminated
- 2010-03-31
- Location
- Canton, MA
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