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 and Swivel Elbow with Suction because their cleaning and sterilization instructions are inadequate. This could lead to improper reuse of the tubes on patients, potentially causing infection or other complications.
The product's instructions for cleaning and sterilization are incomplete. Specifically, the manual does not specify how to clean the tubes, how long an autoclave cycle should last, or how many times the tubes can safely be reused on a single patient. This could lead to improper sterilization and potential infection risks.
Healthcare professionals using these devices in medical settings are most at risk, particularly those who reuse the tubes without following proper sterilization protocols.
Check for the product name 'DuraLife Autoclavable Silicone Extension Tube' with reference number 60-1510 (UltraSet Product Code 66-2505) or the Swivel Elbow with Suction Port. Lot numbers include 3572938, 3709023, 3917565, and other numbers listed in the recall notice.
Identify the product by checking the reference number 60-1510 (UltraSet Product Code 66-2505) and lot numbers listed in the recall notice.
The recall is due to inadequate cleaning and sterilization instructions in the product's manual, which do not specify cleaning methods, autoclave cycle duration, or safe reuse limits.
The recall notice does not specify a remedy, so you should check with Smiths Medical for guidance on safe handling or disposal.
Yes, the recall includes specific lot numbers such as 3572938, 3709023, 3917565, and others listed in the notice.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1582-2023 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1582-2023 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.
