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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bag, bile collecting
Product CodeEXF
Regulation Number 876.5010
Device Class 2

MDR Year MDR Reports MDR Events
2018 6 6
2019 1 1
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 5 5
Fluid/Blood Leak 2 2
Device Emits Odor 1 1
Device Inoperable 1 1
Defective Component 1 1
Defective Device 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Information 3 3
No Code Available 1 1
Insufficient Information 1 1
Nausea 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Remington Medical Inc. III Jun-02-2011
2 Remington Medical, Inc. II Dec-05-2023
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