DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
FDA Recall Z-2296-2021 · Posted None
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Recalling FirmDelta Med SpA
Recall StatusOpen, Classified
Product CodeFOZ
Date Initiated2021-06-21
Product Quantity203,680 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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