BD Blood Collection Assembly with Male Luer Lock — Class II medical device recall Z-1122-2019
Terminated recall by Becton Dickinson & Company, reported 2019-04-17, distributed in FL, NJ. The luer could break and cause the device to leak or break off and get stuck in the fistula needle port render
| Recall number | Z-1122-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2019-03-07 |
| Classified | 2019-04-10 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2020-05-12 |
| Distributed | FL, NJ |
| Quantity | 6,509,600 |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 50885403235915 |
| Model numbers | MBC6010 |
Product
BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
Reason for recall
The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cannulated with a new fistula needle to obtain their dialysis treatment.
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-1122-2019. 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.