Device product
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
Z-0366-2017
Product summary
- Firm
- Covidien LLC
- Event
- Event 75302
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4950 units
- Official record key
device-enforcement:Z-0366-2017
Official wording
Reason: Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
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
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
Derived failure modes
-
Unknown
Added Instructions for Use: After application, inspect the Light Glove for barrier integrity