Recall Z-2297-2021— Delta Med SpA

Name: FDA recall Z-2297-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-21

Class II · Ongoing

Class II FDA medical device recall by Delta Med SpA, initiated 2021-06-21. It names one FDA 510(k) clearance: K171530. Product: 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) REF 3847773 y) REF 3800573. Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device.

Recalling firm: Delta Med SpA
Classification: Class II
Status: Ongoing
Initiated: 2021-06-21
Firm location: Viadana, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K171530 — Deltaven XiV Max, Deltaven XiV Max FFDelta Med Spa·cleared 2017-12-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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) REF 3847773 y) REF 3800573

Reason for recall

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

Data sourced from openFDA. This site is unofficial and independent of the FDA.