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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cystometric gas (carbon-dioxide) on hydraulic device
Product CodeFAP
Regulation Number 876.1620
Device Class 2

MDR Year MDR Reports MDR Events
2018 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Spes Medica II Jun-25-2021
2 Teleflex Medical Europe Ltd II Apr-12-2018
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