FDAFDA · Food and drugs·Recall number Z-1781-2021
Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
Published June 9, 2021 · Recall initiated: April 1, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
single use devices labeled as sterile may not have been adequately sterilized
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CLINICAL LASERTHERMIA SYSTEMS AB
- Distributor
- Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland.
- Lot
- Lot ID: 116540030718, 116540201117
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
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