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Open, Classified

DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072

FDA Recall Z-2298-2021 · Posted None

Recalling FirmDelta Med SpA
Recall StatusOpen, Classified
Product CodeFOZ
Date Initiated2021-06-21

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.

K171530Deltaven XiV Max, Deltaven XiV Max FFDelta Med Spa · 2017-12-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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