Recall Z-2490-2021 ยท GAA Needle, Aspiration And Injection, Disposable
M.D.L. S.r.l.
Aspirated Cyto-Histological Biopsy needle
| Date | Aug 5, 2021 |
| Status | Terminated |
| Reason | Sterility assurance may be compromised. |
| Root cause | Other |
| Action | The firm disseminated an URGENT: MEDICAL DEVICE RECALL notice on 08/05/2021 by email. The notice explained the issue and requested the return of any unused products. Distributors were instructed to notify their customers. |
| Quantity | 2750 devices |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.