Smiths Medical recalls ProPort Plastic Venous Access Systems with specific lot numbers due to risk of port housing separation. Affected units may need replacement to prevent potential complications.
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Smiths Medical is recalling a specific type of venous access system because a manufacturing defect could cause the port housing and reservoir to separate. This separation might lead to complications if the device is used without proper maintenance.
The plastic port housing and reservoir may separate due to a manufacturing defect. This separation could cause the device to malfunction or become dislodged, potentially leading to complications during medical procedures.
Patients using the ProPort Plastic Venous Access System with the listed lot numbers are most at risk. Healthcare providers who have this device in their inventory should also check for affected units.
Check the lot numbers on the device: 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.
Look for the lot numbers listed: 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 recalled device is Smiths Medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer.
Check the lot numbers on your device: 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 recall record does not specify a remedy, so contact Smiths Medical directly for guidance on next steps.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1283-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1283-2025 from Smiths Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
