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Tenex Health Inc recalls TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray).
Recalled May 14, 2014 · FDA recall Z-1552-2014 · Tenex Health
Hazard
The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mechanical impact. · FDA Class II
Units
9,927 units
Sold at
Worldwide Distribution - USA (Nationwide) and Internationally to Panama and Singapore.
Description
The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mechanical impact.
Product
TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.
Manufacturer(s)
Tenex Health Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →