Smiths Medical recalls Y-Piece 15mm portex tubing with uncertain sterile packaging seal integrity. Affected units have specific UDI/DI and lot numbers. Consumers should contact Smiths Medical for details.
Uncertainty in the seal integrity of the sterile packaging.
Smiths Medical is recalling Y-Piece 15mm portex tubing due to uncertainty in the sterile packaging seal. This could lead to contamination if the tubing is used in medical procedures. Affected units have specific UDI/DI and lot numbers.
The sterile packaging seal may not be reliable, potentially allowing contamination of the tubing. This could lead to infections or other complications during medical procedures if the tubing is used without proper sterility.
Healthcare professionals using the portex tubing for medical procedures are most at risk. Patients receiving treatments with this tubing could be affected if the packaging seal is compromised.
Check for the UDI/DI numbers 35019315011003 and 35019315022405, and lot numbers 4131841, 4122012, or 4133227 on the packaging.
Look for UDI/DI numbers 35019315011003 or 35019315022405 and lot numbers 4131841, 4122012, or 4133227 on the packaging.
The recall states uncertainty in the sterile packaging seal, but the product is not inherently dangerous if used correctly with intact packaging.
Check for UDI/DI numbers 35019315011003 or 35019315022405 and lot numbers 4131841, 4122012, or 4133227 on the packaging.
Contact Smiths Medical directly for further instructions as the recall remedy is not specified in the record.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0145-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0145-2025 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.
