Smiths Medical ProPort Plastic Venous Access System Recalled for Port Housing Separation Risk
Smiths Medical is recalling certain ProPort Plastic Venous Access System devices due to a manufacturing defect that may cause the port housing and reservoir to separate.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification establishes a minimum severity of Severe (4) per the rubric. No injuries or deaths are reported in the source text, so the classification does not qualify for Critical (5).
Plain-English summary
Smiths Medical ASD, Inc. is recalling the ProPort Plastic Implantable Ports venous access system due to a manufacturing defect. The plastic port housing and port reservoir may separate.
The affected device is the ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter (reference number 21-4173-24, Lot Number 4317077). The recall involves 12 units that were distributed worldwide.
A separation of the port housing and reservoir could affect the proper function of the implanted device.
The recalled product
- Product
- smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 12
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 10610586012747
- Lot Numbers: 4317077
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 12 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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