Device product
PIVO Blood Collection Device 20G, REF: 202-0005
Z-0527-2022
Product summary
- Firm
- Velano Vascular
- Event
- Event 89185
- Status
- Terminated
- Classification
- Class II
- Quantity
- 123,700
- Official record key
device-enforcement:Z-0527-2022
Official wording
Reason: 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.
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.
Derived failure modes
-
Microbial contamination
microbial contamination
-
Sterility assurance
breach in the sterile barrier