Smiths Medical ASD, Inc.: smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24

Hazard

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

Details from the source

Reason for recall: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. Distribution: Worldwide distribution. Quantity: 2236 units Lot/code info: UDI/DI 10610586012839, Lot Numbers: 3906623, 3922514, 4120026, 4152690, 4157409, 4196736, 4227806, 4264408, 4271442, 4317086, 4337691, 4382350, 4387734, 4405011, 4440712, 4445592, 4460621, 4468591, 6013085, 6026683, 6037136, 6051319, 6071259.

UPC codes

10610586012839

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.