RecallDepth

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

Company
Delta Med Spa Via Guido Rossa 20 Viadana Italy
Recall Initiated
June 21, 2021
Recall Number
Z-2298-2021

Reason for Recall

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

Distribution

US Nationwide distribution in the states of FL and MN.

Lot / Code Info

a) REF 3832072, Lot 11T80190 b) REF 3810072, Lot 11T80303 c) REF 3842072, Lot 12T80342 d) REF 3852072, Lot 12T80348

Root Cause

Process control

Action Taken

The firm disseminated the notices on 06/21/2021 by email. The firm is requesting destruction of the affected devices at the consignee.

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