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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, collection, capillary blood
Regulation Description Capillary blood collection tube.
Product CodeGIO
Regulation Number 864.6150
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1
2019 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Manufacturing, Packaging or Shipping Problem 1 1
Tube 1 1
Break 1 1
Material Puncture/Hole 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 2 2
Visual Impairment 1 1
Dyspnea 1 1
Toxicity 1 1
Cognitive Changes 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Radiometer Medical ApS II Jun-03-2020
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