Recall Z-1781-2021— CLINICAL LASERTHERMIA SYSTEMS AB
Class II · Terminated
Class II FDA medical device recall by CLINICAL LASERTHERMIA SYSTEMS AB, initiated 2021-04-01, terminated 2023-08-30. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: single use devices labeled as sterile may not have been adequately sterilized.
- Recalling firm
- CLINICAL LASERTHERMIA SYSTEMS AB
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-01
- Terminated
- 2023-08-30
- Firm location
- Lund, Sweden
Product description
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.
Reason for recall
single use devices labeled as sterile may not have been adequately sterilized
Data sourced from openFDA. This site is unofficial and independent of the FDA.