Recall Z-1552-2014— Tenex Health Inc

Name: FDA recall Z-1552-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-14

Class II · Terminated

Class II FDA medical device recall by Tenex Health Inc, initiated 2014-04-14, terminated 2014-07-16. It names one FDA 510(k) clearance: K123640. 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.. Reason: 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..

Recalling firm: Tenex Health Inc
Classification: Class II
Status: Terminated
Initiated: 2014-04-14
Terminated: 2014-07-16
Firm location: Lake Forest, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K123640 — TX1 TISSUE REMOVAL SYSTEMTenex Health·cleared 2013-03-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.