TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray).

FDA device recall Z-1552-2014 · posted 2014-05-06 · Terminated

Recall details

Recalling firm

Tenex Health Inc

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.

Action taken

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.

Root cause

Packaging

Status

Terminated

Product code

LFL

Quantity affected

9,927 units

Distribution

Worldwide Distribution - USA (Nationwide) and Internationally to Panama and Singapore.

Date initiated

2014-04-14

Date posted

2014-05-06

Date terminated

2014-07-16

Location

Lake Forest, CA

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