CLINICAL LASERTHERMIA SYSTEMS AB recalls Tranberg MR Cannula (REF 401:05) due to potential inadequate sterilization of single-use sterile devices. This affects medical devices used with the Tranberg MR Introducer for laser tissue procedures.
single use devices labeled as sterile may not have been adequately sterilized
CLINICAL LASERTHERMIA SYSTEMS AB is recalling Tranberg MR Cannulas (REF 4013-05) because single-use sterile devices may not have been properly sterilized. This could lead to infections if used in medical procedures.
Single-use sterile devices labeled as such may not have been adequately sterilized during manufacturing. This could result in infections if the devices are used in medical procedures without proper sterilization.
Healthcare professionals who use these cannulas for laser procedures are most at risk. Patients receiving these devices during medical treatments may be affected if the cannulas are not properly sterilized.
Check for the product name 'Tranberg MR Cannula' with reference number 4013-05. These devices are used with the Tranberg MR Introducer for laser tissue procedures and were sold with lot numbers 116539201117 and 116539030718.
Look for lot numbers 116539201117 or 116539030718 on the cannula packaging.
The recall is due to single-use sterile devices potentially not being adequately sterilized during manufacturing.
Using devices that may not be properly sterilized could lead to infections during medical procedures.
Check for the product name 'Tranberg MR Cannula' with reference number 4013-05 and lot numbers 116539201117 or 116539030718.
We’ve drafted a message you can send Tranberg to request your refund or repair — edit it as you like.
Subject: Recall Z-1780-2021 — Tranberg Tranberg Hello, I own a Tranberg that is covered by recall Z-1780-2021 from Tranberg. 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.
