FDA Device recall Z-1782-2021
Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the T…
- FDA Device
- Class II
- terminated
- Published 2021-06-09
On 2021-06-09 the FDA classified a Class II recall of Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the T… by Clinical Laserthermia Systems Ab, citing single use devices labeled as sterile may not have been adequately sterilized.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1782-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-01 |
| Published | 2021-06-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Clinical Laserthermia Systems Ab |
| Distribution | US |
Product
Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, 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
Identifiers
| code_info | Lot # 00247/2019/11, 00029/2020/02, 00076/2020/03, 00177/2018/10-1, 00177/2018/10-2, 00049/2020/02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1782-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.