Smiths Medical recalls DuraLife Autoclavable Double Swivel Elbows with suction ports 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 Double Swivel Elbows with suction ports because their cleaning and sterilization instructions are inadequate. This could lead to improper reuse on patients, potentially causing infections or other health risks.
The product's instructions for cleaning and sterilization do not specify how long to run the autoclave cycle, how many times the device can be reused on a single patient, or the cleaning method. This could lead to improper reuse and potential infection risks.
Healthcare professionals using these swivel elbows in medical settings. Patients receiving care with these devices may be at risk if the elbows are reused improperly.
Check for lot numbers: 3577218, 3738865, 3887812, 4024574, 4151070, 4258733, and other numbers listed in the recall notice. These swivel elbows have suction ports and are used with breathing circuits.
Look for the lot numbers listed in the recall notice to determine if your swivel elbow is affected.
Reach out to Smiths Medical for further guidance on the recall and potential remedies.
The product's instructions for cleaning and sterilization are inadequate, specifically not providing the cleaning method, duration of autoclave cycle, or number of cycles the product can be reused on a single patient.
Lot numbers include 3577218, 3738865, 3887812, 4024574, 4151070, 4258733, and others listed in the recall notice.
Check if your swivel elbow has a suction port and matches the lot numbers listed in the recall 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-1580-2023 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1580-2023 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.
