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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 NONWOVENS
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 1
ANDERSEN STERILIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDINAL HEALTH 200, LLC
  SUBSTANTIALLY EQUIVALENT 4
CASE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 6
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
SAFE SECURE PACKAGING CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIGMA
  SUBSTANTIALLY EQUIVALENT 2
SIGMA MEDICAL SUPPLIES CORP.
  SUBSTANTIALLY EQUIVALENT 2
STANDARD TEXTILE CO., INC.
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
SYMMETRY MEDICAL INC- MANCHESTER
  SUBSTANTIALLY EQUIVALENT 1
TIANCHANG JIARUI PACKAGING MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device Disinfection Or Sterilization Issue 10
Problem with Sterilization 7
Material Discolored 6
Material Integrity Problem 4
Material Puncture / Hole 3
Hole In Material 3
Residue After Decontamination 3
Contamination During Use 2
Material Fragmentation 2
Failure To Adhere Or Bond 2
Device Issue 2
Product Quality Problem 2
Material Deformation 1
Device Contamination with Chemical or Other Material 1
Device Contaminated during manufacture or shipping 1
Metal Shedding Debris 1
Out-Of-Box Failure 1
Tear, Rip or Hole in Device Packaging 1
Defective Component 1
Detachment of Device or device Component 1
Manufacturing, Packaging or Shipping Problem 1
Adverse Event Without Identified Device or Use Problem 1
Thermal Decomposition of Device 1
Fire 1
Shipping Damage or Problem 1
Total Device Problems 59

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Sterilization Products II Mar-23-2015
2 Steris Corporation II Feb-27-2018

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