Recall Z-2305-2021 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Delta Med SpA
WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
| 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 | 40,000 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 |