Smiths Medical ASD, Inc.: smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24

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: 2311 units Lot/code info: UDI/DI 10610586012549, Lot Numbers: 3928188, 3953708, 3957301, 3968097, 3977434, 3988450, 4006475, 4022600, 4027912, 4036893, 4073108, 4086999, 4103105, 4114110, 4122783, 4136362, 4139518, 4152689, 4153871, 4173433, 4189866, 4222392, 4227822, 4235597, 4276226, 4307472, 4317085, 4349806, 4378522, 4387732, 4395511, 4460618, 4434228, 4449233, 4449875, 6013082, 6014983, 4468606, 4426417, 6062037, 6071256.

UPC codes

10610586012549

Source

Official record: FDA (Device enforcement) ↗

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