FDA Device Recall Z-0366-2017: Covidien LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0366-2017.

Recall Res Number

Z-0366-2017

Recalling Firm / Manufacturer

Covidien LLC

FEI Number

1219930

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2016-09-29

Date Posted

N/A

Date Terminated

2019-04-05

Product Code

LRO

Event Number

75302

Product Quantity

4950 units

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

Action Details 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

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

Code Information / Serial Numbers All lot codes in the following: Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK

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Medical Device Recall: Z-0366-2017

Recall Parameters & Description

Related Establishments / Registrations

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