FDA recall Z-1781-2021

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.

Reason for recall

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

Distribution

Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland.

Key facts

Status

Terminated

Initiation date

2021-04-01

Report date

2021-06-09

Termination date

2023-08-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lund, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1781-2021