Apligraf (Graftskin)
FDA device recall Z-0068-2007 · posted 2006-10-24 · Terminated
Recall details
- Recalling firm
- Organogenesis, Inc.
- Reason for recall
- Product pH out of specification
- Action taken
- Organogenesis notified customers by fax on 9/29/06 through 10/2/06. Follow-Up telephone calls are being made. Users are requested to examine units for pH and return if product is out of spec., or verify unit was in spec for pH at time of use.
- Root cause
- Other
- Status
- Terminated
- Product code
- MGR
- Quantity affected
- 58
- Distribution
- Nationwide
- Date initiated
- 2006-09-29
- Date posted
- 2006-10-24
- Date terminated
- 2007-03-12
- Location
- Canton, MA
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