FDA Device recall Z-1112-2021
Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994)
- FDA Device
- Class I
- terminated
- Published 2021-02-24
On 2021-02-24 the FDA classified a Class I recall of Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994) 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-1112-2021 |
| 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
Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.
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: MFG2267, MFG2347, MFG2375, MFG2430, MFG2538, MFG2637, MFG2655, MFG2693, MFG2708, MFG2754, MFG2828, MFG312…Lot Numbers: MFG2267, MFG2347, MFG2375, MFG2430, MFG2538, MFG2637, MFG2655, MFG2693, MFG2708, MFG2754, MFG2828, MFG3120, MFG3186, MFG3340, MFG3378, MFG3386, MFG3586, MFG3640 |
|---|
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-1112-2021%22
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