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COVIDIEN LLC recalls EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage:
Recalled October 10, 2018 · FDA recall Z-0070-2019 · COVIDIEN
Hazard
The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue. · FDA Class II
Units
1,902
Sold at
Worldwide Distribution - US Nationwide in the states of CA, FL, IL, NC, NY, UT. and the countries of Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Reunion, Spain, Sweden, Switzerland, and United Kingdom.
Description
The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.
Product
EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.
Manufacturer(s)
COVIDIEN LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →