Bifircated Extension Set — Class II medical device recall Z-1468-2015
Terminated recall by Churchill Medical Systems, Inc., reported 2015-04-29, distributed nationwide. Potential for leaking caused by insufficient bond between needleless device and female luer.
| Recall number | Z-1468-2015 |
|---|---|
| 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 | 2015-01-15 |
| Classified | 2015-04-21 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2016-02-25 |
| Distributed | Nationwide (US) |
| Quantity | 100 |
| Reason classes | packaging |
Product
Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids
Reason for recall
Potential for leaking caused by insufficient bond between needleless device and female luer.
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-1468-2015. 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.