DUET TRS 60 4.8MM STRAIGHT SULU Product Code: DUET6048 Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULU

FDA device recall Z-0997-2012 · posted 2012-02-13 · Terminated

Recall details

Recalling firm

Covidien LP

Reason for recall

Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death

Action taken

Covidien issued an Urgent Medical Device Recall letter dated January 12, 2012 to all affected customers. The letter identified the affected products, problem, and actions to be taken. Customers were instructed to immediately discontinue use of the device in thoracic surgery, Immediately advise all surgeons/surgery personnel of this recall and return products intended for thoracic use to Covidien by contacting Customer Service at SDFeedback@Covidien.com or 1-800-722-8772, option 1, to obtain a Return Goods Authorization prior to returning the affected units. Customers were advised to complete the Recall product return form in its entirety and return it with the returned units. For questions contact your Covidien representative or Quality Assurance at 203-492-5232.

Root cause

Under Investigation by firm

Status

Terminated

Product code

GDW

Quantity affected

9,687 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of: ¿esk¿ republika, ASSAGAY, Australia, Austria, Belgium, Bosnia, Herzegovina, Bulgaria Cairo,Egypt, Canada, Canary Islands, China, Croatia

Date initiated

2012-01-12

Date posted

2012-02-13

Date terminated

2016-08-24

Location

North Haven, CT