Smiths Medical ASD, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1284-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.
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

Product Classification:

Class I

Date Initiated: February 13, 2025
Date Posted: March 26, 2025
Recall Number: Z-1284-2025
Event ID: 96294
Reason for Recall:

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

Status: Ongoing
Product Quantity: 1 unit
Code Information:

UDI/DI 10610586012723, Lot Numbers: 4235509

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated