Smiths Medical recalls Thermovent 1200 15mm/22mm devices with specific serial numbers due to potential seal integrity issues in sterile packaging.
Uncertainty in the seal integrity of the sterile packaging.
Smiths Medical is recalling certain Thermovent 1200 15mm/22mm devices because their sterile packaging might not seal properly. This could lead to contamination of the medical device if the packaging is compromised. Affected users should check their product serial numbers against the listed lots to determine if they are included in this recall.
The sterile packaging for these devices may not seal properly, potentially allowing contaminants to enter the device. This could lead to infection or other complications if the device is used without proper sterility.
Healthcare professionals using the Thermovent 1200 devices for medical procedures are most at risk if the packaging seal fails. Patients using these devices may be affected if the packaging becomes compromised during use.
Check the product's serial number (UDI/DI) and lot numbers listed in the recall notice. The affected models include REF 100/582/000, REF 100/582/000JP, and REF 100/582/000JS with specific serial numbers and lot numbers provided.
Compare your device's UDI/DI and lot numbers with the list provided in the recall notice to determine if it is affected.
Smiths Medical recalls these devices due to uncertainty in the seal integrity of the sterile packaging, which could lead to contamination.
Check your device's UDI/DI and lot numbers against the specific lists provided in the recall notice for REF 100/582/000, REF 100/582/000JP, and REF 100/582/000JS.
The recall notice does not specify a remedy, so affected users should contact Smiths Medical directly for further instructions.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0147-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0147-2025 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.
