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U.S. Department of Health and Human Services

Class 2 Device Recall Professional Hospital Supply,

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 Class 2 Device Recall Professional Hospital Supply,see related information
Date Initiated by FirmSeptember 29, 2016
Create DateNovember 08, 2016
Recall Status1 Terminated 3 on April 05, 2019
Recall NumberZ-0366-2017
Recall Event ID 75302
Product Classification General surgery tray - Product Code LRO
ProductProfessional 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
Code Information 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 
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information ContactSAME
203-492-5000
Manufacturer Reason
for Recall		Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
FDA Determined
Cause 2		Process control
ActionMedtronic 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
Quantity in Commerce4950 units
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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