Z-0527-2022 Class II Terminated
FDA device recall Z-0527-2022 was initiated by Velano Vascular on November 10, 2021 and is designated Class II. 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. Th… The recall status is terminated (terminated July 31, 2023). Affected quantity: 123,700.
Recall Details
- Product Type
- Devices
- Report Date
- February 2, 2022
- Initiation Date
- November 10, 2021
- Termination Date
- July 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 123,700
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.
Distribution Pattern
US Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC.
Code Information
UDI: 00850984007027. Lots: 070621-02, 062221-01, 061021-02, 052721-03, 051421-02