Z-2296-2021 Class II Ongoing

Recalled by Delta Med SpA — Viadana, N/A

Recall Details

Product Type
Devices
Report Date
August 25, 2021
Initiation Date
June 21, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
203,680 units

Product Description

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

Reason for Recall

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

Distribution Pattern

US Nationwide distribution in the states of FL and MN.

Code Information

a) REF 3832572: Lot 11T80189 b) REF 3842572, Lot 11T80198 c) REF 3821572, Lot 11T80149 d) REF 3833572, Lot 11T80292 e) REF 3831572, Lot 12T80230 f) REF 3810572, Lot 12T80302 g) REF 3852572, Lot 12T80349