Velano Vascular: Medical Device Recall in 2022 - (Recall #: Z-0527-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

PIVO Blood Collection Device 20G, REF: 202-0005

Product Classification:

Class II

Date Initiated: November 10, 2021

Date Posted: February 2, 2022

Recall Number: Z-0527-2022

Event ID: 89185

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.

Status: Terminated

Product Quantity: 123,700

Code Information:

UDI: 00850984007027. Lots: 070621-02, 062221-01, 061021-02, 052721-03, 051421-02

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated