Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
2026 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 38 38
Short Fill 36 36
Leak/Splash 32 32
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Device Markings/Labelling Problem 11 11
Difficult to Remove 9 9
Unsealed Device Packaging 7 7
Contamination 7 7
Separation Problem 6 6
False Positive Result 6 6
Overfill 6 6
Tear, Rip or Hole in Device Packaging 6 6
Fluid/Blood Leak 5 5
Premature Separation 5 5
Break 4 4
Device Ingredient or Reagent Problem 3 3
Separation Failure 3 3
Material Discolored 3 3
Component Missing 3 3
Activation, Positioning or Separation Problem 2 3
Compatibility Problem 2 2
Fracture 2 2
Material Separation 2 2
Failure to Seal 1 1
Loss of or Failure to Bond 1 1
Improper or Incorrect Procedure or Method 1 1
Connection Problem 1 1
Coagulation in Device or Device Ingredient 1 1
Protective Measures Problem 1 1
Device Dislodged or Dislocated 1 1
Product Quality Problem 1 1
Incorrect Measurement 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Handling Problem 1 1
Packaging Problem 1 1
Material Deformation 1 1
Delivered as Unsterile Product 1 1
Infusion or Flow Problem 1 1
Material Twisted/Bent 1 1
Use of Device Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Difficult to Insert 1 1
Defective Device 1 1
Defective Component 1 1
Insufficient Information 1 1
Crack 1 1
Volume Accuracy Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device-Device Incompatibility 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 217 217
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 Medline Industries, LP II May-07-2026
7 Medline Industries, LP II Apr-30-2026
8 Medline Industries, LP II Feb-17-2026
9 Meridian Bioscience Inc II Dec-08-2023
-
-