Recall Z-0656-2022 ยท NNI Container, Specimen, Non-Sterile
MEDLINE INDUSTRIES, LP - Northfield
Michels Transport Medium, 20ML Prefilled Cont
| Date | Dec 1, 2021 |
| Status | Terminated |
| Reason | Product stored incorrectly in temperature controlled setting instead of refrigeration. |
| Root cause | Process control |
| Action | Medline notified customer through first class mail on about 12/01/2021, via letter titled URGENT RECALL NOTIFICATION. Customers were instructed to immediately check stock and quarantine affected devices, return the completed provided response form indicating affected product on hand and destroyed, and to notify customers if affected product was further distributed. An amended customer letter was sent on 12/17/2021. The explanation of the issue was updated. Instructions remained the same. |
| Quantity | 2,816 units (22 cases, 128 per case) |
| Distribution | US Nationwide distribution in the states of Colorado, Florida, New York, North Carolina, and Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.