FDA Device recall Z-1780-2021
Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer
- FDA Device
- Class II
- terminated
- Published 2021-06-09
On 2021-06-09 the FDA classified a Class II recall of Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer 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-1780-2021 |
| 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 MR Cannula, REF: 4013-05, 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 ID: 116539201117 and 116539030718 M |
|---|
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-1780-2021%22
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