Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living, bilayered skin substitute
FDA device recall Z-1747-2011 · posted 2011-03-23 · Terminated
Recall details
- Recalling firm
- Organogenesis, Inc.
- Reason for recall
- Product sterility may be compromised
- Action taken
- Organogenesis contacted the accounts by telephone and fax on 2/24/11 to advise of the contamination and identification fo the organism for appropriate patient follow-up.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- MGR
- Quantity affected
- 7 units
- Distribution
- Nationwide.
- Date initiated
- 2011-02-21
- Date posted
- 2011-03-23
- Date terminated
- 2011-07-28
- Location
- Canton, MA
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