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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wrap, sterilization
Product CodeFRG
Regulation Number 880.6850
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
AHLSTROM NONWOVENS LLC
  SUBSTANTIALLY EQUIVALENT 2
AHLSTROM-MUNKSJO NONWOVENS LLC
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 1
ANDERSEN STERILIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 4
ANDERSEN STERILIZERS,INC.
  SUBSTANTIALLY EQUIVALENT 2
ARJO WIGGINS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BH MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH 200 LLC
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH 200, LLC
  SUBSTANTIALLY EQUIVALENT 10
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES
  SUBSTANTIALLY EQUIVALENT 3
CARE ESSENTIALS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
CASE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
CPAC, INC.
  SUBSTANTIALLY EQUIVALENT 1
DUKAL LLC
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL PACKAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
HALYARD HEALTH
  SUBSTANTIALLY EQUIVALENT 1
HINSON AND HALE MEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU ZHANDE MEDICAL SUPPLIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KENPAX INTERNATIONAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 7
KIMBERLY-CLARK HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 5
LAC MAC, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MDK (SHANGHAI) MEDICAL PACKING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 7
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
OWENS & MINOR (O&M) HALYARD, INC
  SUBSTANTIALLY EQUIVALENT 1
OWENS & MINOR (O&M) HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
OWENS& MINOR HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
PLASMAPP CO,.LTD.
  SUBSTANTIALLY EQUIVALENT 1
PLASMAPP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PMS MEDIKAL AMBALAJ SANAYI VE TICARET LTD STI
  SUBSTANTIALLY EQUIVALENT 1
PMS TIBBI CIHAZLAR TEKNOLOJISI SAN VE TIC AS
  SUBSTANTIALLY EQUIVALENT 1
PMS TIP TEKNOLOJILERI SANAYI VE TICARET LIMITED STD
  SUBSTANTIALLY EQUIVALENT 1
QIANJIANG KINGPHAR MEDICAL PACKAGING & PRINTING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAFE SECURE PACKAGING CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SAFE SECURE PACKING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIGMA MEDICAL SUPPLIES CORP.
  SUBSTANTIALLY EQUIVALENT 3
SIGMA MEDICAL SUPPLIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SOLIDENCE SURGICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STANDARD TEXTILE CO., INC.
  SUBSTANTIALLY EQUIVALENT 2
STERILERIGHT PACKAGING MFG., INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
SYMMETRY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SYMMETRY MEDICAL INC- MANCHESTER
  SUBSTANTIALLY EQUIVALENT 1
TIANCHANG JIARUI PACKAGING MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TURBETT SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
TURBETT SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
U&U MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
U&U MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WEIHAI XINGTAI PACKAGING PRODUCTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
WIPAK OY
  SUBSTANTIALLY EQUIVALENT 6
WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 13 13
2015 9 9
2016 20 20
2017 7 7
2018 22 22
2019 10 10
2020 21 21
2021 9 9
2022 4 4
2023 13 13
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Hole In Material 17 17
Crack 15 15
Device Disinfection Or Sterilization Issue 11 11
Residue After Decontamination 8 8
Problem with Sterilization 7 7
Material Split, Cut or Torn 7 7
Material Puncture/Hole 6 6
Material Discolored 6 6
Contamination 5 5
Product Quality Problem 5 5
Cut In Material 5 5
Device Contamination with Chemical or Other Material 5 5
Device Operates Differently Than Expected 4 4
Material Deformation 4 4
Material Integrity Problem 4 4
Difficult to Open or Remove Packaging Material 3 3
Tear, Rip or Hole in Device Packaging 3 3
Defective Component 3 3
Material Separation 3 3
Delivered as Unsterile Product 2 2
Material Fragmentation 2 2
Failure To Adhere Or Bond 2 2
Break 2 2
Device Issue 2 2
Detachment of Device or Device Component 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Torn Material 2 2
Appropriate Term/Code Not Available 2 2
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Unexpected Color 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Packaging Problem 1 1
Physical Property Issue 1 1
Component Missing 1 1
Out-Of-Box Failure 1 1
Defective Device 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Thermal Decomposition of Device 1 1
Fire 1 1
Melted 1 1
Device Emits Odor 1 1
Metal Shedding Debris 1 1
Material Perforation 1 1
Shipping Damage or Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 51 51
No Clinical Signs, Symptoms or Conditions 40 40
No Information 12 12
No Consequences Or Impact To Patient 12 12
No Patient Involvement 5 5
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Code Available 2 2
Missing Value Reason 1 1
Not Applicable 1 1
Patient Problem/Medical Problem 1 1
Urticaria 1 1
Burn(s) 1 1
Failure of Implant 1 1
Itching Sensation 1 1
Swelling 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Sterilization Products II Mar-23-2015
2 Advanced Sterilization Products III Dec-03-2013
3 Kimberly-Clark Corporation II Mar-26-2013
4 Steris Corporation II Jan-21-2021
5 Steris Corporation II Feb-27-2018
6 TURBETT SURGICAL, LLC II May-18-2022
7 Turbett Surgical, Inc. II Jan-30-2023
8 Turbett Surgical, Inc. II Aug-04-2022
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