TPLC - Total Product Life Cycle

• Device: wrap, sterilization
• Regulation Description: Sterilization wrap.
• Product Code: FRG
• Regulation Number: 880.6850
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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
GEORGE COUREY INC.
	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
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
TURBETT SURGICAL
	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
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
2020	21	21
2021	9	9
2022	4	4
2023	13	13
2024	21	21
2025	17	17

Device Problems	MDRs with this Device Problem	Events in those MDRs
Crack	15	15
Contamination	12	12
Material Puncture/Hole	9	9
Material Discolored	8	8
Material Split, Cut or Torn	7	7
Residue After Decontamination	5	5
Difficult to Open or Remove Packaging Material	3	3
Product Quality Problem	3	3
Device Contamination with Chemical or Other Material	3	3
Break	2	2
Defective Component	2	2
Material Integrity Problem	2	2
Material Separation	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 /Decontamination Problem	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	59	59
Unspecified Infection	11	11
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