Recall Z-2295-2021 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Delta Med SpA
DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
| Date | Jun 21, 2021 |
| Status | Open, Classified |
| Reason | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device |
| Root cause | Process control |
| Action | The firm disseminated the notices on 06/21/2021 by email. The firm is requesting destruction of the affected devices at the consignee. |
| Quantity | 30,900 units |
| Distribution | US Nationwide distribution in the states of FL and MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171530 | Deltaven XiV Max, Deltaven XiV Max FF Delta Med Spa, Dec 21, 2017 |