FDA Devices Moderate Class II Terminated

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

Reported: November 16, 2016 Initiated: September 29, 2016 #Z-0366-2017

Product Description

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

Reason for Recall

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

Details

Recalling Firm: Covidien LLC
Units Affected: 4950 units
Distribution: 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 Arab Emirates United Kingdom
Location: North Haven, CT

Frequently Asked Questions

What product 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. Recalled by Covidien LLC. Units affected: 4950 units.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on November 16, 2016. Severity: Moderate. Recall number: Z-0366-2017.

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