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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
AHLSTROM NONWOVENS LLC
  SUBSTANTIALLY EQUIVALENT 2
ANDERSEN STERILIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ANDERSEN STERILIZERS,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 1
CARE ESSENTIALS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
CASE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU ZHANDE MEDICAL SUPPLIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MDK (SHANGHAI) MEDICAL PACKING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
OWENS & MINOR (O&M) HALYARD, INC
  SUBSTANTIALLY EQUIVALENT 1
OWENS& MINOR HALYARD, INC.
  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
SAFE SECURE PACKAGING CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SAFE SECURE PACKING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIGMA MEDICAL SUPPLIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIGMA MEDICAL SUPPLIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STANDARD TEXTILE CO., INC.
  SUBSTANTIALLY EQUIVALENT 2
STERILERIGHT PACKAGING MFG., INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
TIANCHANG JIARUI PACKAGING MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TURBETT SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
TURBETT SURGICAL LLC
  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 2

MDR Year MDR Reports MDR Events
2016 20 20
2017 7 7
2018 22 22
2019 10 10
2020 21 21
2021 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 15 15
Hole In Material 11 11
Device Disinfection Or Sterilization Issue 11 11
Problem with Sterilization 7 7
Material Discolored 5 5
Residue After Decontamination 5 5
Cut In Material 5 5
Material Puncture/Hole 4 4
Material Separation 3 3
Defective Component 3 3
Contamination 3 3
Device Contamination with Chemical or Other Material 3 3
Material Deformation 3 3
Material Integrity Problem 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Material Split, Cut or Torn 2 2
Tear, Rip or Hole in Device Packaging 2 2
Detachment of Device or Device Component 2 2
Material Fragmentation 2 2
Delivered as Unsterile Product 2 2
Failure To Adhere Or Bond 2 2
Break 2 2
Product Quality Problem 2 2
Shipping Damage or Problem 1 1
Component Missing 1 1
Out-Of-Box Failure 1 1
Metal Shedding Debris 1 1
Thermal Decomposition of Device 1 1
Fire 1 1
Device Emits Odor 1 1
Device Contaminated During Manufacture or Shipping 1 1
Connection Problem 1 1
Device Issue 1 1
Output Problem 1 1
Packaging Problem 1 1
Physical Property Issue 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 45 45
No Clinical Signs, Symptoms or Conditions 22 22
No Consequences Or Impact To Patient 11 11
No Patient Involvement 3 3
No Information 2 2
Insufficient Information 2 2
No Code Available 1 1
Missing Value Reason 1 1
Patient Problem/Medical Problem 1 1
Burn(s) 1 1
Failure of Implant 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Steris Corporation II Jan-21-2021
2 Steris Corporation II Feb-27-2018
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