CLINICAL LASERTHERMIA SYSTEMS AB recalls Tranberg MR Stylets (REF: 4013-06) due to potential inadequate sterilization. These single-use sterile devices may not be properly sterilized, risking infection.
single use devices labeled as sterile may not have been adequately sterilized
CLINICAL LASERTHERMIA SYSTEMS AB is recalling Tranberg MR Stylets (1.8mm/15G, 230mm, REF: 4013-06) because single-use devices labeled as sterile may not have been adequately sterilized. This could lead to infection if used improperly.
Single-use sterile devices labeled as sterile may not have been adequately sterilized. This means the stylets could be contaminated and pose an infection risk if used in medical procedures.
Healthcare professionals who use these stylets with the Tranberg MR Laser System for medical procedures. Patients receiving procedures using these stylets are at risk of infection.
Check for the product name 'Tranberg MR Stylet', model 1.8mm/15G, 230mm, and reference number 4013-06. These stylets are used with the Tranberg MR Laser System and are labeled as sterile.
Look for the product name, model, and reference number on the stylet packaging or label.
The stylets may not have been adequately sterilized, which could lead to infection if used in medical procedures.
The official recall notice does not specify a remedy or action steps for affected users.
The recall indicates a potential risk of inadequate sterilization, so it is not recommended to use these stylets without confirming they have been properly sterilized.
We’ve drafted a message you can send CLINICAL LASERTHERMIA SYSTEMS AB to request your refund or repair — edit it as you like.
Subject: Recall Z-1781-2021 — CLINICAL LASERTHERMIA SYSTEMS AB CLINICAL LASERTHERMIA SYSTEMS AB Hello, I own a CLINICAL LASERTHERMIA SYSTEMS AB that is covered by recall Z-1781-2021 from CLINICAL LASERTHERMIA SYSTEMS AB. 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.
