Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfad
FDA device recall Z-0936-2013 · posted 2013-03-11 · Terminated
Recall details
- Recalling firm
- Bacterin International, Inc.
- Reason for recall
- A portion of a silicone wound drain was found to be cracked.
- Action taken
- Consignees were informed of the recall via e-mail beginning 1/28/13 with a request for a return response. This was followed by a "Voluntary Product Recall Information" letter dated 2/13/13 that described the product issue and provided recommended actions. The firm asked for all product to be returned to them.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- OEI
- Quantity affected
- 15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee
- Distribution
- 13 US consignees located in CA, CO, MT, TX, UT, and VA. This represents 4 customers and 9 other individual contacts in USA that received marketing samples. Plus 4 Bacterin representives nationwide rec
- Date initiated
- 2013-01-28
- Date posted
- 2013-03-11
- Date terminated
- 2013-07-08
- 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 |