Smiths Medical ProPort Plastic Implantable Ports Recalled for Port Housing Separation
Smiths Medical is recalling 1961 units of ProPort Plastic Implantable Ports worldwide due to a manufacturing defect that may cause the port housing and reservoir to separate. This Class I recall affects patients dependent on venous access systems.
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 recall—the agency's highest classification—requires a minimum severity score of 4. Although no reported illnesses or deaths are stated in the source, the manufacturing defect that could cause an implanted port to separate from its catheter poses significant risk to patients dependent on venous access.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the ProPort Plastic Venous Access System, a medical implant that provides venous access for patients requiring intravenous therapy. The affected product is the PolyFlow Catheter variant (2.6/7.8Fr outer diameter, 1.6mm inner diameter, 8.5Fr introducer, reference 21-4171-24). A total of 1961 units have been distributed worldwide.
The plastic port housing and port reservoir may separate due to a manufacturing defect. This defect creates a risk that the implanted port could disconnect during use, potentially compromising the patient's venous access.
Patients with this implanted port should contact their healthcare provider immediately to verify whether their device is affected. Healthcare providers should use the affected lot numbers to identify patients and determine appropriate clinical action. The FDA has classified this as a Class I recall, the agency's highest classification.
The affected lot numbers are: 3941279, 3969275, 3984421, 4022601, 4136364, 4148590, 4153873, 4196768, 4227788, 4232310, 4235600, 4248718, 4276227, 4302980, 4307478, 4317093, 4325880, 4358053, 4358054, 4395512, 4415445, 4420760, 4437255, 4449234, 4449877, 4460620, 6013083, 6003891, 6053532, 6062026. The unique device identifier (UDI/DI) is 10610586012716.
The recalled product
- Product
- smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 1,961
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 10610586012716
- Lot Numbers: 3941279
- 3969275
- 3984421
- 4022601
- 4136364
- 4148590
- 4153873
- 4196768
- 4227788
- 4232310
- 4235600
- 4248718
- 4276227
- 4302980
- 4307478
- 4317093
- 4325880
- 4358053
- 4358054
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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