Wound Drain — Class II medical device recall Z-1680-2014
Terminated recall by Bacterin International, Inc., reported 2014-06-11. The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/
| Recall number | Z-1680-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bacterin International, Inc., Belgrade, MT, United States |
| Recall initiated | 2014-05-15 |
| Classified | 2014-06-02 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2014-06-02 |
| Countries outside the US | LB |
| Quantity | 390 |
| Lot numbers | 016913, 028013, 028113, 028213 |
| Model numbers | 7110, 7118 |
Product
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1680-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.