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Terminated

DUET TRS 60 4.8MM ARTICULATING SULU Product Code: DUET6048A Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. When used with the ENDO GIA Universal and Ultra Staplers, the Duet TRS Reloads with Biosyn tissue reinforcement place two, triple-staggered rows titanium staples while simultaneously dividing the tissue and anchoring the preloaded Biosyn reinforcement material. The preloaded reinforcement material Is fully detached from the SULU upon complete firing of the length of the cartridge. The Duet TRS reinforcement material (Biosyn) Is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate.

FDA Recall Z-0998-2012 · Posted 2012-02-13

Recalling FirmCovidien LP
Recall StatusTerminated
Product CodeGDW
Date Initiated2012-01-12
Date Terminated2016-08-24
Product Quantity220,622 units

Reason for Recall

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

Firm Action

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 [email protected] 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

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of: ¿esk¿ republika, ASSAGAY, Australia, Austria, Belgium, Bosnia, Herzegovina, Bulgaria Cairo,Egypt, Canada, Canary Islands, China, Croatia, Cyprus, Czech Republic, Denmark, Egypt, England, Finland, France, Germany, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kingdom of Bahrain, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Luxembourg, Nederland, Nelspruit, New Redruth, New Zealand, Norway, Nouvelle Caledonie, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Romania, Rustenburg, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Taiwan, Thailand, Tunisia, Uae, Uae - Dubai, Umhlanga Rocks, United Kingdom, Vietnam and Wales.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080898AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENTTyco Healthcare Group LP · 2008-05-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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