Recall Z-1552-2014 ยท LFL Instrument, Ultrasonic Surgical
Tenex Health Inc
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.
| Date | May 6, 2014 (initiated Apr 14, 2014) |
| Status | Terminated |
| 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. |
| Root 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 dam |
| Quantity | 9,927 units |
| Distribution | Worldwide Distribution - USA (Nationwide) and Internationally to Panama and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123640 | TX1 TISSUE REMOVAL SYSTEM Tenex Health, Mar 20, 2013 |