Bionector Needleless connector — Class II medical device recall Z-0113-2015
Terminated recall by Vygon Corporation, reported 2014-10-29, distributed in CA. Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector
| Recall number | Z-0113-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vygon Corporation, Lansdale, PA, United States |
| Recall initiated | 2014-08-28 |
| Classified | 2014-10-22 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2015-03-30 |
| Distributed | CA |
| Quantity | 42,250 |
| Lot numbers | 070214EE, 210314EE, 280314EE, 291113EE |
Product
Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.
Reason for recall
Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector.
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-0113-2015. 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.