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TX1 Tissue Removal System. TX1 Procedure Pack P/N… recallZ-1552-2014 · Tenex Health Inc · initiated Apr 14, 2014

Class II Terminated All recalls posted in May 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Tenex Health Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Packaging

What the company is doing

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 [email protected]. For questions regarding this recall call (949) 454-7500.

Recall details

Recall number
Z-1552-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 14, 2014
Posted by the FDA
May 6, 2014
Recalling firm
Tenex Health Inc
Quantity
9,927 units
Product code
LFL
FDA submissions
K123640
Distribution
Worldwide Distribution - USA (Nationwide) and Internationally to Panama and Singapore.

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.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Other devices under the same FDA submission

1 device cleared under K123640 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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