Device 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.
Z-1782-2021
Product summary
- Event
- Event 87808
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 units
- Official record key
device-enforcement:Z-1782-2021
Official wording
Reason: single use devices labeled as sterile may not have been adequately sterilized
Code information: Lot # 00247/2019/11, 00029/2020/02, 00076/2020/03, 00177/2018/10-1, 00177/2018/10-2, 00049/2020/02
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland.
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized