Covidien product recalled over sterility concerns

Recall date

September 29, 2016

Source

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

Official notice title

Covidien LLC recalls Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use co…

Recall number

Z-0365-2017

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

Worldwide Distribution - US Nationwide Foreign: Canada: Andorra Austria Belgium Czech Republic Denmark Finland France Germany Greece Ireland Israel Italy Latvia Luxembourg Monaco Netherlands Norway Poland Portugal Russian Federation Saudi Arabia Slovenia South Africa Spain Sweden Switzerland United…

Why it was recalled

Added Instructions for Use: After application, inspect the Light Glove for barrier integrity

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

What was recalled

Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles