PIVO Blood Collection Device 20G, REF: 202-0005
Reported: February 2, 2022 Initiated: November 10, 2021 #Z-0527-2022
Product Description
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.
Details
- Recalling Firm
- Velano Vascular
- Units Affected
- 123,700
- Distribution
- US Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC.
- Location
- San Francisco, CA
Frequently Asked Questions
What product was recalled? ▼
PIVO Blood Collection Device 20G, REF: 202-0005. Recalled by Velano Vascular. Units affected: 123,700.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 2, 2022. Severity: Moderate. Recall number: Z-0527-2022.
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