Home / Recalls / Smiths Medical ASD, Inc. / Z-1285-2025

Z-1285-2025 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
12 units

Product Description

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24

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 10610586012747, Lot Numbers: 4317077

Other recalls by Smiths Medical ASD, Inc.

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  • Z-1682-2025 Class I — CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, (April 10, 2025)
  • Z-1668-2025 Class I — CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21- (April 10, 2025)
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  • Z-1282-2025 Class I — smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow (February 13, 2025)
  • Z-1277-2025 Class I — smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O. (February 13, 2025)
  • Z-1289-2025 Class I — Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111 (February 13, 2025)