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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 1
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 2
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
PMS TIBBI CIHAZLAR TEKNOLOJISI SAN VE TIC AS
  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
SOLIDENCE SURGICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STANDARD TEXTILE CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
STERILERIGHT PACKAGING MFG., INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
TIANCHANG JIARUI PACKAGING MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TURBETT SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
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
2017 7 7
2018 22 22
2019 10 10
2020 21 21
2021 9 9
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 15 15
Device Disinfection Or Sterilization Issue 10 10
Residue After Decontamination 8 8
Problem with Sterilization 7 7
Material Discolored 5 5
Hole In Material 4 4
Material Puncture/Hole 4 4
Defective Component 3 3
Contamination 3 3
Device Contamination with Chemical or Other Material 3 3
Material Integrity Problem 3 3
Tear, Rip or Hole in Device Packaging 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Detachment of Device or Device Component 2 2
Material Split, Cut or Torn 2 2
Material Fragmentation 2 2
Delivered as Unsterile Product 2 2
Break 2 2
Material Separation 2 2
Shipping Damage or Problem 1 1
Product Quality 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
Material Deformation 1 1
Connection Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Output Problem 1 1
Packaging Problem 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 30 30
No Clinical Signs, Symptoms or Conditions 25 25
No Consequences Or Impact To Patient 9 9
Insufficient Information 2 2
No Information 2 2
No Code Available 1 1
No Patient Involvement 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
3 TURBETT SURGICAL, LLC II May-18-2022
4 Turbett Surgical, Inc. II Aug-04-2022
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