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.
Reported: June 9, 2021 Initiated: April 1, 2021 #Z-1782-2021
Product Description
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 for Recall
single use devices labeled as sterile may not have been adequately sterilized
Details
- Recalling Firm
- CLINICAL LASERTHERMIA SYSTEMS AB
- Units Affected
- 90 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland.
- Location
- Lund
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by CLINICAL LASERTHERMIA SYSTEMS AB. Units affected: 90 units.
Why was this product recalled? ▼
single use devices labeled as sterile may not have been adequately sterilized
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 9, 2021. Severity: Moderate. Recall number: Z-1782-2021.
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