Low Titer Type O FWB Transfusion Set — Class I medical device recall Z-1112-2021
Terminated recall by Combat Medical Systems, LLC, reported 2021-02-24, distributed nationwide. There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
| Recall number | Z-1112-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Combat Medical Systems, LLC, Harrisburg, NC, United States |
| Recall initiated | 2020-12-23 |
| Classified | 2021-02-18 |
| Reported by FDA | 2021-02-24 |
| Terminated | 2024-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 1,021 units |
| UPC / GTIN / UDI-DI | 00651501684994 |
| Lot numbers | MFG2267, MFG2347, MFG2375, MFG2430, MFG2538, MFG2637, MFG2655, MFG2693, MFG2708, MFG2754, MFG2828, MFG3120, MFG3186, MFG3340, MFG3378, MFG3386, MFG3586, MFG3640 |
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 for recall
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1112-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.