Smiths Medical ProPort Venous Access System Recalled for Port Separation Risk
Smiths Medical is recalling ProPort Plastic Venous Access Systems due to a manufacturing defect that can cause the port housing and reservoir to separate. This may result in device failure affecting patients worldwide.
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: FDA Class I medical device recall for a manufacturing defect affecting an implantable venous access port. FDA Class I classification requires a minimum severity score of 4; while no reported deaths or serious injuries are mentioned in the source, the potential for device failure and patient complications meets the Severe criterion.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the ProPort Plastic Venous Access System (model REF 21-4172-24, UDI 10610586012723), an implantable venous access port, due to a manufacturing defect.
A defect in the plastic port housing and port reservoir can cause them to separate. This separation could compromise the device's function and patient safety.
The affected product (lot 4235509) has been distributed worldwide. Patients who have received this implant should contact their healthcare provider immediately to discuss any concerns or if they experience symptoms related to their port.
Healthcare providers should stop using the affected lot and contact Smiths Medical ASD, Inc. or the FDA to report any adverse events associated with this device.
The recalled product
- Product
- smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- manufacturing-defect
- component-separation
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 (2)
- UDI/DI 10610586012723
- Lot Numbers: 4235509
Distribution
Distribution scope not specified by the agency.
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