PIVO Blood Collection Device 20G — Class II medical device recall Z-0527-2022
Terminated recall by Velano Vascular, reported 2022-02-02, distributed nationwide. Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclos
| Recall number | Z-0527-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Velano Vascular, San Francisco, CA, United States |
| Recall initiated | 2021-11-10 |
| Classified | 2022-01-25 |
| Reported by FDA | 2022-02-02 |
| Terminated | 2023-07-31 |
| Distributed | Nationwide (US) |
| Quantity | 123,700 |
| Reason classes | microbial contamination, sterility |
| UPC / GTIN / UDI-DI | 00850984007027 |
| Lot numbers | 051421-02, 052721-03, 061021-02, 062221-01, 070621-02 |
| Model numbers | 202-0005 |
Product
PIVO Blood Collection Device 20G, REF: 202-0005
Reason for recall
Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial contamination of the device prior to use. The health effects range from no clinical effect up to bloodstream infection.
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-0527-2022. 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.