CLINICAL LASERTHERMIA SYSTEMS AB Recall 87808
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.
CLINICAL LASERTHERMIA SYSTEMS AB Recall 87808 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1781-2021 |
| Event ID | 87808 |
| Event 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. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland. |
| Quantity | 40 units |
| Recall Reason | single use devices labeled as sterile may not have been adequately sterilized |
| Device Classification | 20210609 |
| Device Code Info | Lot ID: 116540030718, 116540201117 |
| Center Classification Date | 20210603 |
| Recall Initiation Date | 20210401 |
| Recalling Firm | CLINICAL LASERTHERMIA SYSTEMS AB |
| Initial Notification | Letter |
| Similar To |