Combat Medical Systems, LLC Recall 87084
Description: Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor.
Combat Medical Systems, LLC Recall 87084 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1114-2021 |
| Event ID | 87084 |
| Event Description | Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor. |
| Product Type | Devices |
| Distribution | US Nationwide Distribution |
| Quantity | 954 units |
| Recall Reason | There is the potential of a bent or disconnected needle in one of the components of the convenience kits. |
| Device Classification | 20210224 |
| Device Code Info | Lot Numbers: MFG2977, MFG2991, MFG3073, MFG3118, MFG3279, MFG3328, MFG3332, MFG3337, MFG3339, MFG3499, MFG3507, MFG3512, MFG3533, MFG3704, MFG3751, MFG3761, MFG3760, MFG3857 |
| Center Classification Date | 20210218 |
| Recall Initiation Date | 20201223 |
| Recalling Firm | Combat Medical Systems, LLC |
| Initial Notification | |
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