Recall Z-2297-2021 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Delta Med SpA
DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x
| 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 | 229,320 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 |