medical Class I Updated 2025-03-26

Smiths Medical ASD, Inc. recalls smiths medical ProPort Plastic Venous Access System, Pre-ass

Recalled Product

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24

Hazard / Issue

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

Issued by

FDA

Distribution: Worldwide distribution.
Lot/Code Info: UDI/DI 10610586012686, Lot Numbers: 3918902, 3984420, 4079312, 4189868, 4221726, 4235543, 4242787, 4294897, 4307477, 4356314, 4364692, 4390226, 4445595, 4468593, 6003890.
View official government recall

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