Smiths Medical ProPort Implantable Port Risk of Component Separation
Smiths Medical is recalling its ProPort Plastic Implantable Ports due to a manufacturing defect that may cause the port housing and reservoir to separate, potentially compromising device function.
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 mandates a minimum severity score of 4 per the rubric. No reported illnesses or injuries exist in the source; the Severe rating reflects the Class I designation and the potential for device malfunction in an implantable medical system.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the ProPort Plastic Implantable Ports due to a manufacturing defect that may cause the plastic port housing and port reservoir to separate. This defect could compromise the device's function.
The affected product is a venous access system (implantable port) with UDI/DI 10610586012594. Approximately 3,263 units of the affected lot numbers have been distributed worldwide. Healthcare providers and patients using this device should be alert for potential separation of the port housing and reservoir components.
This is a Class I recall, indicating the most serious type of safety issue according to FDA classification standards.
The recalled product
- Product
- smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 3,263
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 10610586012594
- Lot Numbers: 3926119
- 3928191
- 3944833
- 3960347
- 3968098
- 3988451
- 4027913
- 4057817
- 4087000
- 4139520
- 4146467
- 4173474
- 4196758
- 4221725
- 4235599
- 4256939
- 4291484
- 4295931
- 4302979
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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Similar recalls
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