Recall Z-2354-2019 ยท FPA Set, Administration, Intravascular
Molded Products Inc
Luer Lock Set - Catalog # MPC-125, for IV administration sets.
| Date | Jun 10, 2019 |
| Status | Terminated |
| Reason | Mislabeling - Some unit of sale packages (bags of 100 sets of MPC-125) were found to be incorrectly labeled as Molded Products Male to Male Luer Adapters, Catalog # MPC-150. |
| Root cause | Packaging process control |
| Action | On June 10, 2019, the firm sent URGENT MEDICAL DEVICE RECALL letters to their consignees advising them of the labeling problem, requesting that they check their stock, notify their end users and complete the attached MEDICAL DEVICE RECALL CUSTOMER RESPONSE FORM. |
| Quantity | 130,000 sets |
| Distribution | Distribution US nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925927 | MPC-1000 INJECTION CAP/PLUG Molded Products, Inc., Aug 16, 1993 |