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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tray, blood collection
Product CodeGJE
Regulation Number 862.1675
Device Class 2

MDR Year MDR Reports MDR Events
2014 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment Of Device Component 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1
Connection Problem 1 1
Device Operates Differently Than Expected 1 1
Fail-Safe Problem 1 1
Reset Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Nov-16-2023
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