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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
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 2
GEORGE COUREY, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG MAIDI MEDICAL CO., LTD.
  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, LP
  SUBSTANTIALLY EQUIVALENT 2
O&M HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
OWENS & MINOR (O&M) HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
PLASMAPP CO,., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PRIMED MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PROPPER MANUFACTURING CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
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
STERIVIC MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TURBETT SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TURBETT SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WELLMED DENTAL MEDICAL SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WIPAK OY
  SUBSTANTIALLY EQUIVALENT 7
WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YICHANG XINXIN PAPER PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 9 9
2022 4 4
2023 13 13
2024 21 21
2025 19 19
2026 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 13 13
Material Puncture/Hole 12 12
Material Split, Cut or Torn 8 8
Material Discolored 8 8
Appropriate Term/Code Not Available 6 6
Residue After Decontamination 5 5
Product Quality Problem 4 4
Difficult to Open or Remove Packaging Material 3 3
Device Contamination with Chemical or Other Material 3 3
Material Integrity Problem 2 2
Particulates 2 2
Material Separation 2 2
Output Problem 1 1
Peeled/Delaminated 1 1
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Delivered as Unsterile Product 1 1
Material Deformation 1 1
Unexpected Color 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
Unspecified Infection 11 11
Insufficient Information 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Laceration(s) 1 1
Pain 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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