Valkyrie LTOWB Administration — Class I medical device recall Z-1111-2021
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-1111-2021 |
|---|---|
| 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 | 953 units |
| Lot numbers | MFG3205, MFG3353, MFG3403, MFG3440, MFG3540, MFG3574, MFG3584, MFG3649, MFG3660, MFG3698 |
Product
Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyrie LTOWB Administration Set contains the items needed to administer the blood to the 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-1111-2021. 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.