Recall Z-0936-2013 ยท OEI Drainage Catheter With Antibiotic
Bacterin International, Inc.
Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.
| Date | Mar 11, 2013 (initiated Jan 28, 2013) |
| Status | Terminated |
| Reason | A portion of a silicone wound drain was found to be cracked. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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 received samples. Foreign Consingee |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063245 | ELUTIA COATED CLOSED SURGICAL WOUND DRAIN Bacterin International, Inc., Nov 28, 2007 |