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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
AHLSTROM-MUNKSJO NONWOVENS LLC
  SUBSTANTIALLY EQUIVALENT 1
ANDERSEN STERILIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANQING CLEAN DENTAL INSTRUMENT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARE ESSENTIALS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
COMERCIALIZADORA BREVER
  SUBSTANTIALLY EQUIVALENT 1
DUKAL LLC
  SUBSTANTIALLY EQUIVALENT 1
KENPAX INTERNATIONAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KM CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDICOM ASIA-PACIFIC HOLDINGS LTD. TAIWAN BRANCH.
  SUBSTANTIALLY EQUIVALENT 1
MEDICOM GROUP, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
O&M HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
OWENS & MINOR (O&M) HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
PLASMAPP CO,.LTD.
  SUBSTANTIALLY EQUIVALENT 1
PLASMAPP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PRIMED MEDICAL PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 2
QIANJIANG KINGPHAR MEDICAL PACKAGING & PRINTING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SAFESECURE MEDICAL INFECTION CONTROL TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIGMA MEDICAL SUPPLIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SOLIDENCE SURGICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STERILERIGHT PACKAGING MFG., INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TURBETT SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WEIHAI XINGTAI PACKAGING PRODUCTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
WIPAK OY
  SUBSTANTIALLY EQUIVALENT 7
WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 21 21
2021 9 9
2022 4 4
2023 13 13
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 15 15
Material Puncture/Hole 8 8
Material Split, Cut or Torn 7 7
Material Discolored 7 7
Residue After Decontamination 5 5
Difficult to Open or Remove Packaging Material 3 3
Product Quality Problem 3 3
Break 2 2
Defective Component 2 2
Material Separation 2 2
Device Contamination with Chemical or Other Material 2 2
Appropriate Term/Code Not Available 2 2
Fire 1 1
Output Problem 1 1
Insufficient Information 1 1
Defective Device 1 1
Contamination 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Delivered as Unsterile Product 1 1
Material Deformation 1 1
Packaging Problem 1 1
Unexpected Color 1 1
Device Emits Odor 1 1
Detachment of Device or Device Component 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 53 53
Insufficient Information 5 5
No Known Impact Or Consequence To Patient 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Failure of Implant 1 1
No Code Available 1 1
Laceration(s) 1 1
Pain 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Steris Corporation II Jan-21-2021
2 TURBETT SURGICAL, LLC II May-18-2022
3 Turbett Surgical, Inc. II Jan-30-2023
4 Turbett Surgical, Inc. II Aug-04-2022
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