Smiths Medical recalls ProPort Low Profile Plastic Venous Access Systems with a defect causing port housing and reservoir to separate. Affected units have specific lot numbers and UDI/DI codes. Stop using immediately to prevent potential injury.
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 due to a manufacturing defect that may cause the plastic port housing and reservoir to separate. This could lead to disconnection or injury if the system is used.
The plastic port housing and reservoir may separate due to a manufacturing defect. This separation could cause the system to disconnect during use, potentially leading to injury or infection.
Patients using the ProPort Low Profile Plastic Venous Access System with the listed lot numbers and UDI/DI codes are affected. Healthcare providers who have this specific model in their medical equipment are most at risk.
Check the lot numbers on the product: 3906623, 3922514, 4120026, 4152690, 4157409, 4196736, 4227806, 4264408, 4271442, 4317086, 4337691, 4382350, 4387734, 4405011, 4440712, 4445592, 4460621, 4468591, 6013085, 6026683, 6037136, 6051319, 6071259. Also check the UDI/DI code 10610586012839.
Discontinue use of the ProPort Low Profile Plastic Venous Access System with the listed lot numbers and UDI/DI code.
The recalled product is Smiths Medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer.
Check the lot numbers: 3906623, 3922514, 4120026, 4152690, 4157409, 4196736, 4227806, 4264408, 4271442, 4317086, 4337691, 4382350, 4387734, 4405011, 4440712, 4445592, 4460621, 4468591, 6013085, 6026683, 6037136, 6051319, 6071259. Also check the UDI/DI code 10610586012839.
Stop using the product immediately and contact Smiths Medical for further instructions.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1288-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1288-2025 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.
