Smiths Medical ProPort Venous Ports Recalled for Potential Housing Separation
Smiths Medical is recalling ProPort Low Profile Plastic Venous Access Systems because the plastic port housing and reservoir may separate due to a manufacturing defect. Approximately 8,515 units worldwide are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity score of 4 per the rubric. Although no illnesses or injuries have been reported, the manufacturing defect in this implantable venous access device—potential separation of the port housing and reservoir—poses a realistic risk of serious harm requiring surgical intervention.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the ProPort Low Profile Plastic Venous Access System due to a manufacturing defect that may cause the plastic port housing and port reservoir to separate.
The affected products include the PolyFlow Polyurethane Catheter (1.9mm O.D. x 1.0mm) with 6Fr Introducer, device identifier (UDI/DI) 10610586012778, REF 21-4183-24. A total of 8,515 units have been distributed worldwide across 47 specific lot numbers.
Patients with implanted ProPort systems from the affected lot numbers should contact their healthcare provider. If the port housing and reservoir separate in an implanted device, patients may experience loss of vascular access, potential infection, or need for surgical intervention to remove or replace the port.
The FDA has classified this as a Class I recall. Patients or healthcare providers with questions should contact Smiths Medical ASD, Inc. or their healthcare provider.
The recalled product
- Product
- 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
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- device-separation
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 10610586012778
- Lot Numbers: 3916028
- 3969277
- 4006477
- 4022602
- 4036895
- 4057818
- 4060894
- 4096338
- 4108453
- 4114117
- 4146468
- 4153874
- 4163556
- 4196775
- 4221727
- 4235565
- 4235567
- 4235601
- 4248694
Distribution
Distribution scope not specified by the agency.
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