RecallDepth

NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522

Company
Delta Med Spa Via Guido Rossa 20 Viadana Italy
Recall Initiated
June 21, 2021
Recall Number
Z-2301-2021
Quantity
20,000 units

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 3779422, Lot 00A1160635 b) REF 3769522, Lot 00A1160656 c) REF 3708522, Lot 00A1160638

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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