# FDA recall Z-1780-2021

> **CLINICAL LASERTHERMIA SYSTEMS AB** · Class II · device recall initiated 2021-04-01.

## 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 for recall

single use devices labeled as sterile may not have been adequately sterilized

## Distribution

Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland.

## Key facts

- **Recall number:** Z-1780-2021
- **Recalling firm:** CLINICAL LASERTHERMIA SYSTEMS AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-01
- **Report date:** 2021-06-09
- **Termination date:** 2023-08-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lund, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1780-2021

## Citation

> AI Analytics. FDA recall Z-1780-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1780-2021. Source: US FDA. Licensed CC0.

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