Covidien LLC recalls Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 S…

Recall date

September 29, 2016

Source

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

Recall number

Z-0366-2017

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

Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles