Recall Z-2296-2021 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Delta Med SpA
DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
| 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 | 203,680 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
| K200373 | Deltaven Fast Flash Closed I.V. Catheter Systems Delta Med Spa, Aug 26, 2020 |