Vygon 14 Microbore Extension Set with Bionector — Class II medical device recall Z-2251-2013
Terminated recall by Churchill Medical Systems, Inc., reported 2013-09-25, distributed nationwide. Microbore tubing disconnecting from male luers on the extension sets.
| Recall number | Z-2251-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Churchill Medical Systems, Inc., Dover, NH, United States |
| Recall initiated | 2013-08-12 |
| Classified | 2013-09-18 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2014-06-16 |
| Distributed | Nationwide (US) |
| Quantity | 13,100 |
Product
Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.
Reason for recall
Microbore tubing disconnecting from male luers on the extension sets.
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-2251-2013. 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.