Valkyrie LTOWB Collection — Class I medical device recall Z-1110-2021
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-1110-2021 |
|---|---|
| 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 | 531 units |
| Lot numbers | MFG3204, MFG3327, MFG3350, MFG3455, MFG3541, MFG3573, MFG3582, MFG3648, MFG3659, MFG3671 |
Product
Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the items needed to allow for pre-screening to identify Low Titer Type O Donors as well as collect the blood from the 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-1110-2021. 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.