Class 2 Device Recall TX1 Tissue Removal System

• Date Initiated by Firm: April 14, 2014
• Date Posted: May 06, 2014
• Recall Status: Terminated on July 16, 2014
• Recall Number: Z-1552-2014
• Recall Event ID: 68074
• 510(K)Number: K123640
• Product Classification: Instrument, ultrasonic surgical - Product Code LFL
• 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.
• Code Information: Lot Numbers: 00614-03, 06513-02, 24913-01, 00713-06, 06514-02, 25313-01, 00814-02, 06914-01, 25513-02, 01114-02, 07213-04, 25613-01, 01514-03, 07713-18, 26113-06, 01714-04, 08113-04, 26313-04, 01813-02, 08413-13, 26713-04, 02314-08, 09313-05, 26813-01, 02413-04, 10213-07, 27013-10, 02714-02, 10613-01, 27613-02, 02914-01, 11213-07, 28013-05, 03014-02, 11613-06, 28313-02, 03113-02, 12113-02, 29513-03, 03114-02, 12713-03, 29713-01, 03414-03, 13413-01, 30913-07, 03514-05, 14413-05, 31113-08, 03714-03, 15013-04, 31513-02, 03814-06, 15413-02, 31713-05, 04114-02, 15413-03, 32213-01, 04213-01, 16513-04, 32413-01, 04214-05, 17013-02, 32613-01, 04414-03, 17013-09, 32913-07, 04514-02, 17613-08, 33613-09, 04814-07, 17913-16, 33813-05, 05014-02, 18413-05, 34013-03, 05113-01, 18413-06, 34313-01, 05113-02, 18613-03, 34413-04, 05114-09, 19213-03, 34513-04, 05514-01, 19713-04, 34713-08, 05614-04, 20713-06, 35113-01, 05713-03, 21813-01, 35213-03, 05714-10, 23913-01, 36013-01, 06313-05, 24113-04, 36113-02, 06314-04, 24213-04, and 36413-05.
• Recalling Firm/ Manufacturer: Tenex Health Inc; 26902 Vista Terrance; Lake Forest CA 92630
• For Additional Information Contact: 949-454-7500
• Manufacturer 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.
• FDA Determined Cause: Packaging
• Action: Tenex Health sent an Urgent Medical Device Recall notification letter dated April 15, 2014, to all consigness. The letter informed consignees of the recall, manufacturer, product name, product code, reason for recall, recall carried out to the user level, instructions to customers, contact information, label examples, and response form was provided. Consignees were instructed to immediately examine their inventory per the enclosed instructions, if they identify any of the affected product within their inventory, they should segregate the product and immediately return only MicroTips with damaged trays to the address below, using the Tenex Health, Inc. FEDEX account number and referencing the Returned Goods Authorization (RGA) number. RGA# Tenex Health, Inc. 26902 Vista Terrace Lake Forest, CA 92630 Customers were asked to complete and return the enclosed response form as soon as possible. Customers with questions should contact Tenex at (949) 454-7500, ext. 209 or email tanaka@tenexhealth.com. For questions regarding this recall call (949) 454-7500.
• Quantity in Commerce: 9,927 units
• Distribution: Worldwide Distribution - USA (Nationwide) and Internationally to Panama and Singapore.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LFL