Smiths Medical ASD, Inc.: smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24

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: 9506 units Lot/code info: UDI/DI 10610586012563, Lot Numbers: 3926121, 3928189, 3953709, 3957303, 4006476, 4008521, 4036894, 4046803, 4096337, 4108664, 4114114, 4114115, 4136363, 4146466, 4153872, 4173601, 4232305, 4235508, 4235598, 4271453, 4291483, 4294059, 4317075, 4317092, 4358052, 4366693, 4366694, 4387733, 4434229, 4449244, 4453603, 4453604, 4453605, 6001912, 6026649, 6051324, 6062012, 6071257, 6077416.

UPC codes

10610586012563

Source

Official record: FDA (Device enforcement) ↗

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