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
FDA Recall Z-2297-2021 · Posted None
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Recalling FirmDelta Med SpA
Recall StatusOpen, Classified
Product CodeFOZ
Date Initiated2021-06-21
Product Quantity229,320 units
Reason for Recall
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Firm Action
The firm disseminated the notices on 06/21/2021 by email. The firm is requesting destruction of the affected devices at the consignee.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of FL and MN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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