Device product
Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, 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-1781-2021
Product summary
- Event
- Event 87808
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 units
- Official record key
device-enforcement:Z-1781-2021
Official wording
Reason: single use devices labeled as sterile may not have been adequately sterilized
Code information: Lot ID: 116540030718, 116540201117
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