Recall Z-1680-2014 ยท OEI Drainage Catheter With Antibiotic
Bacterin International, Inc.
Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system.
| Date | Jun 2, 2014 (initiated May 15, 2014) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Use error |
| Action | 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. |
| Quantity | 390 |
| Distribution | Distributed to one foreign consignee in Lebanon. |
| 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 |