Z-0144-2025 Class II Ongoing

Recalled by Smiths Medical ASD Inc. — Minneapolis, MN

Recall Details

Product Type
Devices
Report Date
October 30, 2024
Initiation Date
July 18, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34,141 units

Product Description

smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/150 JS

Reason for Recall

Uncertainty in the seal integrity of the sterile packaging.

Distribution Pattern

Worldwide distribution.

Code Information

a) REF 100/255/150, UDI/DI 35019315022399, Lot Numbers: 4125006; UDI/DI 35019315010990, Lot Numbers: 4159808, 4161750; UDI/DI 35019315011003, Lot Numbers: 4131840; UDI/DI 35019315018156, Lot Numbers: 4131559; UDI/DI 35019315022405, Lot Numbers: 4122011, 4127688; b) REF 100/255/150JP, UDI/DI 35019315010990, Lot Numbers: 4089148, 4107293, 4122008, 4147817, 4138707, 4159808; c) REF 100/255/150 JS, UDI/DI 35019315010990, Lot Numbers: 4122008, 4147817, 4159808