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Velano Vascular recalls PIVO Blood Collection Device 20G, REF: 202-0005
Recalled February 2, 2022 · FDA recall Z-0527-2022 · Velano Vascular
Hazard
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. · FDA Class II
Units
123,700
Sold at
US Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC.
Description
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.
Product
PIVO Blood Collection Device 20G, REF: 202-0005
Manufacturer(s)
Velano Vascular
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →