Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-1780-2021

April 01, 2021

Class II

Product summary

Firm
CLINICAL LASERTHERMIA SYSTEMS AB
Event
Event 87808
Status
Terminated
Classification
Class II
Quantity
40 units
Official record key
device-enforcement:Z-1780-2021

Official wording

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

Code information: Lot ID: 116539201117 and 116539030718 M

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