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Recall Observatory FDA recall evidence

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

April 01, 2021

Class II

Product summary

Firm
CLINICAL LASERTHERMIA SYSTEMS AB
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

    reason.sterility_assurance · v1.0.0

    may not have been adequately sterilized