Smiths Medical ProPort Implantable Port May Separate Due to Manufacturing Defect
Smiths Medical is recalling ProPort Plastic Venous Access Ports because the port housing and reservoir may separate due to a manufacturing defect. Contact your physician if you have an affected device.
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: This is an FDA Class I recall. The agency's classification establishes a minimum severity of 4. The manufacturing defect could cause component separation in an implanted medical device with direct access to the venous system, posing potential serious health consequences. No illnesses or injuries have been reported to date.
Plain-English summary
Smiths Medical ASD, Inc. has recalled the ProPort Plastic Implantable Venous Access System because the plastic port housing and port reservoir may separate due to a manufacturing defect.
The affected lot is 4196769. This device has been distributed worldwide.
Patients with the affected device should contact their physician or healthcare provider to discuss the situation and determine if replacement or other action is needed.
The FDA has classified this as a Class I recall.
The recalled product
- Product
- smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
- Manufacturer
- Smiths Medical ASD, Inc.
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 10610586012754
- Lot Numbers: 4196769
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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