FDA Device recall Z-0527-2022
PIVO Blood Collection Device 20G, REF: 202-0005
- FDA Device
- Class II
- terminated
- Published 2022-02-02
On 2022-02-02 the FDA classified a Class II recall of PIVO Blood Collection Device 20G, REF: 202-0005 by Velano Vascular, citing 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 de….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0527-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-10 |
| Published | 2022-02-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Velano Vascular |
| Distribution | US |
Product
PIVO Blood Collection Device 20G, REF: 202-0005
Reason
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.
Identifiers
| code_info | UDI: 00850984007027. Lots: 070621-02, 062221-01, 061021-02, 052721-03, 051421-02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0527-2022%22
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