Recall Z-2300-2021 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Delta Med SpA
NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
| 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 | 5000 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
| K121007 | NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 Delta Med Srl, Dec 28, 2012 |