PIVO Blood Collection Device recall: Sterility Concern
PIVO Blood Collection Device 20G, REF: 202-0005
Why was PIVO Blood Collection Device 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 00850984007027. Lots: 070621-02, 062221-01, 061021-02, 052721-03, 051421-02
- Product
- PIVO Blood Collection Device 20G, REF: 202-0005
- Recalling firm
- Velano Vascular
- Quantity
- 123,700
- Distribution
- US Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC.
- Recall date
- February 2, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)