FDAFDA · Food and drugs·Recall number Z-1287-2025
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
Published March 26, 2025 · Recall initiated: February 13, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD, Inc.
- Distributor
- Worldwide distribution.
- Lot
- 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.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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