FDA-Device2014-05-14Class II
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.
Tenex Health Inc
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.
Sold states
Worldwide Distribution - USA (Nationwide) and Internationally to Panama and Singapore.
Affected count
9,927 units
Manufactured in
26902 Vista Terrance, N/A, Lake Forest, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1552-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief