Smiths Medical recalls DuraLife Autoclavable Silicone Extension Tubes due to insufficient cleaning and sterilization instructions, risking improper reuse on patients.
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.
Smiths Medical is recalling DuraLife Autoclavable Silicone Extension Tubes because their cleaning and sterilization instructions are inadequate. This could lead to improper reuse of the tubes on patients, potentially causing infections or other complications.
The product's instructions for cleaning and sterilization do not specify the cleaning method, autoclave cycle duration, or how many times the tube can be reused on a single patient. This lack of guidance could lead to improper sterilization and potential contamination.
Healthcare professionals using the DuraLife Autoclavable Silicone Extension Tubes for breathing circuits are likely affected. Patients receiving care with these tubes could be at risk if the tubes are reused improperly.
Check for the product code 60-1502 (UltraSet Product Code 66-2509) on the tube. The tubes are identified by serial numbers listed in the recall notice, such as 3569291, 3802463, and others.
Look for the product code 60-1502 (UltraSet Product Code 66-2509) and serial numbers listed in the recall notice.
The product's instructions for cleaning and sterilization are inadequate, as they do not specify the cleaning method, autoclave cycle duration, or the number of times the tube can be reused on a single patient.
The recall notice does not specify a remedy, so check the product details and contact Smiths Medical for further guidance.
Look for the product code 60-1502 (UltraSet Product Code 66-2509) and serial numbers listed in the recall notice, such as 3569291, 3802463, and others.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1581-2023 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1581-2023 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.
