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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device container, specimen, sterile
Regulation Description Specimen transport and storage container.
Product CodeFMH
Regulation Number 864.3250
Device Class 1

MDR Year MDR Reports MDR Events
2021 22 22
2022 20 20
2023 43 43
2024 39 40
2025 75 75

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 37 37
Leak/Splash 32 32
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Short Fill 13 13
Difficult to Remove 9 9
Unsealed Device Packaging 7 7
False Positive Result 6 6
Tear, Rip or Hole in Device Packaging 6 6
Separation Problem 6 6
Overfill 6 6
Device Markings/Labelling Problem 6 6
Contamination 6 6
Fluid/Blood Leak 5 5
Premature Separation 5 5
Break 4 4
Component Missing 3 3
Material Discolored 3 3
Separation Failure 3 3
Device Ingredient or Reagent Problem 3 3
Material Separation 2 2
Compatibility Problem 2 2
Fracture 2 2
Activation, Positioning or Separation Problem 2 3
Defective Device 1 1
Defective Component 1 1
Insufficient Information 1 1
Crack 1 1
Difficult to Insert 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Volume Accuracy Problem 1 1
Use of Device Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Twisted/Bent 1 1
Infusion or Flow Problem 1 1
Delivered as Unsterile Product 1 1
Material Deformation 1 1
Packaging Problem 1 1
Device Handling Problem 1 1
Incorrect Measurement 1 1
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Protective Measures Problem 1 1
Coagulation in Device or Device Ingredient 1 1
Connection Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of or Failure to Bond 1 1
Fitting Problem 1 1
Failure to Seal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 186 186
Insufficient Information 8 8
Exposure to Body Fluids 2 3
No Consequences Or Impact To Patient 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypersensitivity/Allergic reaction 1 1
Rash 1 1
Needle Stick/Puncture 1 2
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Klinika Mdical Gmb II May-15-2025
2 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
5 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
6 Meridian Bioscience Inc II Dec-08-2023
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