Fresh Whole Blood Donor Set — Class I medical device recall Z-1114-2021
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-1114-2021 |
|---|---|
| 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 | 954 units |
| Lot numbers | MFG2977, MFG2991, MFG3073, MFG3118, MFG3279, MFG3328, MFG3332, MFG3337, MFG3339, MFG3499, MFG3507, MFG3512, MFG3533, MFG3704, MFG3751, MFG3760, MFG3761, MFG3857 |
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 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-1114-2021. 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.