Smiths Medical recalls ProPort Plastic Venous Access Systems with specific lot numbers due to risk of port housing separation from manufacturing defects. Affected units may need replacement.
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Smiths Medical is recalling certain ProPort Plastic Venous Access Systems because the plastic port housing and reservoir can separate due to a manufacturing defect. This could lead to complications if the system becomes dislodged during medical use.
The plastic port housing and reservoir can separate due to a manufacturing defect. This separation could cause the system to become dislodged during medical procedures, potentially leading to complications or infection.
Patients using the ProPort system for venous access, particularly those with implanted ports, are most at risk. Healthcare providers administering treatments through this system may also be affected.
Check the lot numbers listed: 3926121, 3928189, 3953709, 3957303, 4006476, 4008521, 4036894, 4046803, 4096337, 4108664, 4114114, 4114115, 4136363, 4146466, 4153872, 4173601, 4232305, 4235508, 4235598, 4271453, 4291483, 4294059, 4317075, 4317092, 4358052, 4366693, 4366694, 4387733, 4434229, 4449244, 4453603, 4453604, 4453605, 6001912, 6026649, 6051324, 6062012, 6071257, 6077416. The product includes a specific catheter size and reference number.
Identify the lot numbers on your device to see if they are listed in the recall.
Reach out to Smiths Medical for guidance on next steps if your device is affected.
The plastic port housing and reservoir may separate due to a manufacturing defect, which could lead to dislodgement during medical use.
Check the lot numbers listed in the recall to see if your device is affected. If so, contact Smiths Medical for guidance.
The recall record does not specify a remedy, so no immediate fix is provided.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1280-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1280-2025 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.
