Recall Z-1122-2019 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
| Date | Mar 7, 2019 |
| 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. |
| Root cause | Process change control |
| Action | Urgent Medical Device Recall notification letters dated 3/7/19 were distributed to customers. |
| Quantity | 6,509,600 |
| Distribution | US distribution to the states of FL and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972404 | VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) Bd Becton Dickinson Vacutainer Systems Preanalytic, Jul 22, 1997 |