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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device wrap, sterilization
Product CodeFRG
Regulation Number 880.6850
Device Class 2


Premarket Reviews
ManufacturerDecision
ANDERSEN STERILIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BH MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH 200 LLC
  SUBSTANTIALLY EQUIVALENT 1
CARE ESSENTIALS PTY LTD
  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 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
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
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
STERILERIGHT PACKAGING MFG., INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
TIANCHANG JIARUI PACKAGING MATERIAL CO., LTD.
  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 2
WIPAK OY
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2018 22 22
2019 10 10
2020 21 21
2021 9 9
2022 4 4

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 27 27
No Clinical Signs, Symptoms or Conditions 25 25
No Consequences Or Impact To Patient 9 9
Insufficient Information 3 3
Failure of Implant 1 1
Patient Problem/Medical Problem 1 1
No Code Available 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 Jan-30-2023
5 Turbett Surgical, Inc. II Aug-04-2022
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