Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 un
FDA device recall Z-1680-2014 · posted 2014-06-02 · Terminated
Recall details
- Recalling firm
- Bacterin International, Inc.
- Reason for recall
- The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/verifications on the affected products. All of the affected products were appropriately sterilized
- Action taken
- Bacterin sent e-mail and FedEx letter with return receipt request to it's single consignee on May 15, 2014. Consignee is asked to separate the recalled product in a secure location for return to Bacterin International, Inc. Consignee is asked to complete tracking/verification form included in the letter/e-mail and call 1-888-886-9354 from 8:00AM to 5:00PM (Mountain Time) or send an e-mail to CS@Bacterin.com to obtain a Return Authorization (RA) number.
- Root cause
- Use error
- Status
- Terminated
- Product code
- OEI
- Quantity affected
- 390
- Distribution
- Distributed to one foreign consignee in Lebanon.
- Date initiated
- 2014-05-15
- Date posted
- 2014-06-02
- Date terminated
- 2014-06-02
- Location
- Belgrade, MT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELUTIA COATED CLOSED SURGICAL WOUND DRAIN (K063245) | Bacterin International, Inc. | 2007-11-28 |