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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device indicator, biological sterilization process
Product CodeFRC
Regulation Number 880.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
3M
  SUBSTANTIALLY EQUIVALENT 1
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 21
3M COMPANY-3M HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 1
3M COMPLANY
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 9
ADVANCED STERILIZATION PRODUCTS (ASP)
  SUBSTANTIALLY EQUIVALENT 3
ANDERSEN STERILIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 4
ANDERSEN STERILIZERS,INC.
  SUBSTANTIALLY EQUIVALENT 1
BCR DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CROSSTEX INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
CROSSTEX/SPSMEDICAL, A DIVISION OF CANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
DANA PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
GKE-GMBH
  SUBSTANTIALLY EQUIVALENT 1
MESA LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
NORTH AMERICAN SCIENCE ASSOC., INC.
  SUBSTANTIALLY EQUIVALENT 3
PLASMAPP CO,.LTD.
  SUBSTANTIALLY EQUIVALENT 1
PLASMAPP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RAVEN BIOLOGICAL LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SGM BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPS MEDICAL SUPPLY CORP.
  SUBSTANTIALLY EQUIVALENT 2
SPSMEDICAL SUPPLY CORP. A DIVISION OF CANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
STERILUCENT, INC
  SUBSTANTIALLY EQUIVALENT 2
STERILUCENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS
  SUBSTANTIALLY EQUIVALENT 1
  1.  K073618  VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK
  2.  K083665  VERIFY SCBI 275F 3-10
  3.  K090514  VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAP ...
  4.  K092906  VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAP ...
  5.  K140499  VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR ...
  6.  K140708  VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR
  7.  K170070  VERIFY ASSERT STEAM Process Challenge Device for G ...
  8.  K171504  VERIFY Assert VH2O2 Self-Contained Biological Indi ...
  9.  K171587  VERIFY Incubator for Assert VH2O2 Self-Contained B ...
  10.  K172474  Celerity 20 HP Biological Indicator
  11.  K172752  CELERITY 20 HP Biological Indicator
  12.  K173488  CELERITY 20 HP Challenge Pack
  13.  K173626  Celerity 20 Steam Process Challenge Device for Dyn ...
  14.  K173629  CELERITY 20 Steam Process Challenge Device for Gra ...
  15.  K173633  VERIFY All-In-One STEAM Reusable Test Pack, VERIFY ...
  16.  K173634  CELERITY 20 Steam Biological Indicator
  17.  K173670  CELERITY 20 Steam Incubator
  18.  K181429  CELERITY 20 HP Biological Indicator
  19.  K181686  CELERITY 20 Steam Biological Indicator
  20.  K183294  CELERITY 20 HP Biological Indicator, CELERITY HP C ...
  21.  K190297  Celerity HP Incubator
  22.  K200126  VERIFY Assert Self-Contained Biological Indicator
  23.  K202721  Celerity 20 Steam Biological Indicator for IUSS
  24.  K213881  Celerity Incubator
  25.  K223715  Celerity Incubator
  26.  K223717  Celerity 5 HP Biological Indicator; Celerity 5 HP ...
  27.  K231490  Celerity 20 HP Biological Indicator; VERIFY V24 Se ...
  28.  K233681  ConFirm 20 Minute Incubator
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 28
  1.  K073618  VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK
  2.  K083665  VERIFY SCBI 275F 3-10
  3.  K090514  VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAP ...
  4.  K092906  VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAP ...
  5.  K140499  VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR ...
  6.  K140708  VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR
  7.  K170070  VERIFY ASSERT STEAM Process Challenge Device for G ...
  8.  K171504  VERIFY Assert VH2O2 Self-Contained Biological Indi ...
  9.  K171587  VERIFY Incubator for Assert VH2O2 Self-Contained B ...
  10.  K172474  Celerity 20 HP Biological Indicator
  11.  K172752  CELERITY 20 HP Biological Indicator
  12.  K173488  CELERITY 20 HP Challenge Pack
  13.  K173626  Celerity 20 Steam Process Challenge Device for Dyn ...
  14.  K173629  CELERITY 20 Steam Process Challenge Device for Gra ...
  15.  K173633  VERIFY All-In-One STEAM Reusable Test Pack, VERIFY ...
  16.  K173634  CELERITY 20 Steam Biological Indicator
  17.  K173670  CELERITY 20 Steam Incubator
  18.  K181429  CELERITY 20 HP Biological Indicator
  19.  K181686  CELERITY 20 Steam Biological Indicator
  20.  K183294  CELERITY 20 HP Biological Indicator, CELERITY HP C ...
  21.  K190297  Celerity HP Incubator
  22.  K200126  VERIFY Assert Self-Contained Biological Indicator
  23.  K202721  Celerity 20 Steam Biological Indicator for IUSS
  24.  K213881  Celerity Incubator
  25.  K223715  Celerity Incubator
  26.  K223717  Celerity 5 HP Biological Indicator; Celerity 5 HP ...
  27.  K231490  Celerity 20 HP Biological Indicator; VERIFY V24 Se ...
  28.  K233681  ConFirm 20 Minute Incubator
STERIS CORPORATIONS
  SUBSTANTIALLY EQUIVALENT 3
STERITEC PRODUCTS MFG. CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
STERITEC PRODUCTS MFG., CO., INC.
  SUBSTANTIALLY EQUIVALENT 2
TERRAGENE SA
  SUBSTANTIALLY EQUIVALENT 3
TRUE INDICATING LLC
  SUBSTANTIALLY EQUIVALENT 1
TSO3 INC.
  SUBSTANTIALLY EQUIVALENT 1
TSO3 INC., NOW A PART OF STRYKER
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 51 51
2015 182 182
2016 479 479
2017 182 182
2018 22 22
2019 30 30
2020 16 16
2021 10 10
2022 9 9
2023 20 20
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 637 637
Chemical Problem 291 291
Device Operates Differently Than Expected 172 172
Improper or Incorrect Procedure or Method 9 9
Leak/Splash 7 7
Environmental Particulates 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Insufficient Information 7 7
False Positive Result 6 6
Shelf Life Exceeded 5 5
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Use of Device Problem 4 4
Break 3 3
Component Missing 3 3
Contamination /Decontamination Problem 3 3
Contamination of Device Ingredient or Reagent 3 3
Device Contamination With Biological Material 3 3
Device Disinfection Or Sterilization Issue 2 2
Incorrect Or Inadequate Test Results 2 2
Defective Device 2 2
Output Problem 2 2
Fluid/Blood Leak 2 2
Material Fragmentation 2 2
Problem with Sterilization 2 2
Device Damaged Prior to Use 1 1
Microbial Contamination of Device 1 1
Material Rupture 1 1
Material Separation 1 1
Sterility 1 1
Poor Quality Image 1 1
Off-Label Use 1 1
Device Reprocessing Problem 1 1
Device Expiration Issue 1 1
False Negative Result 1 1
Packaging Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Failure of Device to Self-Test 1 1
Improper Chemical Reaction 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Chemical Spillage 1 1
Device Operational Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 466 466
No Known Impact Or Consequence To Patient 461 461
No Clinical Signs, Symptoms or Conditions 46 46
No Consequences Or Impact To Patient 41 41
No Information 17 17
No Code Available 6 6
Burn(s) 4 4
Test Result 3 3
Chemical Exposure 2 2
Insufficient Information 2 2
Eye Pain 1 1
Eye Injury 1 1
Fever 1 1
Infiltration into Tissue 1 1
Laceration(s) 1 1
Respiratory Distress 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
Discomfort 1 1
Injury 1 1
Premature Labor 1 1
Caustic/Chemical Burns 1 1
Patient Problem/Medical Problem 1 1
Abrasion 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Sep-26-2023
2 3M Company - Health Care Business II Jul-07-2014
3 Advanced Sterilization Products II Dec-28-2013
4 Advanced Sterilization Products II Apr-26-2013
5 Advanced Sterilization Products II Dec-12-2012
6 Advanced Sterilization Products II Jul-27-2012
7 Advanced Sterilization Products II Jun-06-2012
8 Advanced Sterilization Products II Oct-20-2009
9 Getinge USA Inc II Aug-21-2013
10 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
11 Mesa Laboratories Bozeman Manufacturing Facility II Mar-29-2018
12 Mesa Laboratories Inc II Jan-26-2017
13 Mesa Laboratories, Inc., Bozeman Manufacturing Facility II Aug-01-2013
14 Steris Corporation II Jan-03-2023
15 Steris Corporation II Dec-28-2013
16 Steritec Products Mfc. Co., Inc. II Jul-29-2013
17 TERRAGENE S.A. II Jan-26-2024
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