Z-1284-2025 Class I Ongoing

Recalled by Smiths Medical ASD, Inc. — Minneapolis, MN

Recall Details

Product Type
Devices
Report Date
March 26, 2025
Initiation Date
February 13, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24

Reason for Recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Distribution Pattern

Worldwide distribution.

Code Information

UDI/DI 10610586012723, Lot Numbers: 4235509