Smiths Medical ASD, Inc.: smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24

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: 3263 units Lot/code info: UDI/DI 10610586012594, Lot Numbers: 3926119, 3928191, 3944833, 3960347, 3968098, 3988451, 4027913, 4057817, 4087000, 4139520, 4146467, 4173474, 4196758, 4221725, 4235599, 4256939, 4291484, 4295931, 4302979, 4307473, 4307474, 4437254, 4447572, 4449876, 4460619, 6037144, 6006017, 6059285, 6026682, 6062025, 6071258.

UPC codes

10610586012594

Source

Official record: FDA (Device enforcement) ↗

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