FDA recall Z-0527-2022

Product

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.

Distribution

US Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC.

Key facts

Status

Terminated

Initiation date

2021-11-10

Report date

2022-02-02

Termination date

2023-07-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Francisco, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0527-2022