Reported Feb 2, 2022 · Terminated
PIVO Blood Collection Device 20G, REF: 202-0005
Velano Vascular
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Velano Vascular · 221 Pine St # 200 · San Francisco, CA · 94104-2705
Is this the product you have?
- PIVO Blood Collection Device 20G
- REF202-0005
- Lot codes and dates
- UDI00850984007027
- Lots
070621-02062221-01061021-02052721-03051421-02
- Amount recalled
- 123,700
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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