Reported Oct 3, 2012 · Terminated
Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6035A. Single Use Loading…
Covidien LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien LP · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
- Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit
- Product CodeDUET6035A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas
- Lot codes and dates
- All lot numbers
- Amount recalled
- 268,022 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Why it was recalled
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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