COVIDIEN LLC recalls EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: Th…

Recall date

August 17, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0070-2019

FDA classification

Class II

Brand / firm

COVIDIEN LLC

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.