Recall Z-0527-2022 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Velano Vascular
PIVO Blood Collection Device 20G, REF: 202-0005
| Date | Nov 10, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | On 11/10/21, recall notices were sent to Medical Directors, Risk Managers, Medical Device Safety Officers, Nurse Managers. 1) Locate and destroy all product subject to the recall following your institution s process for destruction. 2) If the affected product was previously used in patient care and no signs of infection are apparent, no additional steps need to be taken. If the affected product was used in patient care and signs of infection are present, follow your institution s established procedures. 3) Share this recall notification with all users within your facility network of the produc |
| Quantity | 123,700 |
| Distribution | US Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193569 | PIVO(TM) Velano Vascular, Jan 21, 2020 |