Class II — Becton Dickinson & Company
| Recalling firm | Becton Dickinson and Company |
|---|---|
| Registered facility | View this company's 36 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010 |
| Quantity | 6,509,600 |
| Distribution | US distribution to the states of FL and NJ. |
| Initiated | 2019-03-07 |
| Classified | 2019-04-10 |
| Terminated | 2020-05-12 |
| Recall number | Z-1122-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Becton Dickinson & Company (Z-1122-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82317/
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