FDA Device recall Z-1114-2021
Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit
- FDA Device
- Class I
- terminated
- Published 2021-02-24
On 2021-02-24 the FDA classified a Class I recall of Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit by Combat Medical Systems, citing there is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1114-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-12-23 |
| Published | 2021-02-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Combat Medical Systems |
| Distribution | US |
Product
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.
Reason
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Identifiers
| code_info | Lot Numbers: MFG2977, MFG2991, MFG3073, MFG3118, MFG3279, MFG3328, MFG3332, MFG3337, MFG3339, MFG3499, MFG3507, MFG351…Lot Numbers: MFG2977, MFG2991, MFG3073, MFG3118, MFG3279, MFG3328, MFG3332, MFG3337, MFG3339, MFG3499, MFG3507, MFG3512, MFG3533, MFG3704, MFG3751, MFG3761, MFG3760, MFG3857 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1114-2021%22
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