Velano Vascular Recall 89185
Description: PIVO Blood Collection Device 20G, REF: 202-0005
Velano Vascular Recall 89185 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0527-2022 |
| Event ID | 89185 |
| Event Description | PIVO Blood Collection Device 20G, REF: 202-0005 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC. |
| Quantity | 123,700 |
| Recall 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. |
| Device Classification | 20220202 |
| Device Code Info | UDI: 00850984007027. Lots: 070621-02, 062221-01, 061021-02, 052721-03, 051421-02 |
| Center Classification Date | 20220125 |
| Recall Initiation Date | 20211110 |
| Recalling Firm | Velano Vascular |
| Initial Notification | Letter |
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