Medical device recalls Moderate risk

Delta Med SpA recalls DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF…

Recall date
June 21, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2297-2021
FDA classification
Class II
Brand / firm
Delta Med SpA
Sold / distributed
US Nationwide distribution in the states of FL and MN.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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