Smiths Medical ASD, Inc.: smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24

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: 8515 units Lot/code info: UDI/DI 10610586012778, Lot Numbers: 3916028, 3969277, 4006477, 4022602, 4036895, 4057818, 4060894, 4096338, 4108453, 4114117, 4146468, 4153874, 4163556, 4196775, 4221727, 4235565, 4235567, 4235601, 4248694, 4256927, 4256928, 4256964, 4276228, 4294894, 4294895, 4364693, 4366695, 4366696, 4378523, 4382349, 4392370, 4395513, 4405010, 4420761, 4426418, 4434230, 4453606, 4468579, 4468580, 6005957, 6005958, 6026650, 6026651, 6037122, 6037124, 6051325.

UPC codes

10610586012778

Source

Official record: FDA (Device enforcement) ↗

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