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Terminated

Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

FDA Recall Z-0364-2017 · Posted None

Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeLRO
Date Initiated2016-09-29
Date Terminated2019-04-05
Product Quantity13,786,893 in total Distributed in USA

Reason for Recall

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

Firm Action

Medtronic issued a Correction Notice on September 29, 2016. Customers were notified via Federal Express and the letter informed customers of the addition of the following statement to the Instructions for Use (IFU): After application, inspect the Light Glove for barrier integrity. Questions or concerns, contact your Medtronic representative or Customer Service at (800) 962-9888

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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