TPLC - Total Product Life Cycle

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Device	filter, bacterial, breathing-circuit
Regulation Description	Breathing circuit bacterial filter.
Product Code	CAH
Regulation Number	868.5260
Device Class	2

Premarket Reviews
Manufacturer	Decision
AMBU A/S
	SUBSTANTIALLY EQUIVALENT	1
BESMED HEALTH BUSINESS CORP
	SUBSTANTIALLY EQUIVALENT	1
DRÄGERWERK AG & CO. KGAA
	SUBSTANTIALLY EQUIVALENT	1
GREAT GROUP MEDICAL CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
INTERSURGICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
NDD MEDIZINTECHNIK AG
	SUBSTANTIALLY EQUIVALENT	1
NINGBO HUAKUN MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PALL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PASSY-MUIR, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHARMA SYSTEM AB
	SUBSTANTIALLY EQUIVALENT	1
SHAOXING HAITECH MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	53	53
Use of Device Problem	31	31
Crack	29	29
Material Split, Cut or Torn	28	28
Obstruction of Flow	23	25
Loose or Intermittent Connection	17	17
Break	15	15
Filtration Problem	12	12
Material Separation	12	12
Disconnection	10	11
Leak/Splash	10	10
Mechanical Problem	9	10
Connection Problem	9	9
Pressure Problem	8	9
Device Damaged Prior to Use	8	8
Device Markings/Labelling Problem	8	8
Material Puncture/Hole	8	8
Detachment of Device or Device Component	6	6
Contamination	5	5
Failure to Calibrate	4	4
Complete Blockage	4	4
Insufficient Information	4	4
Component Misassembled	4	4
Material Integrity Problem	4	4
Appropriate Term/Code Not Available	3	3
Fracture	3	3
Partial Blockage	3	3
Moisture or Humidity Problem	3	3
Particulates	3	3
Improper Flow or Infusion	3	3
Component Missing	3	3
Device Alarm System	3	3
Defective Device	3	3
Defective Component	3	3
Material Fragmentation	2	2
Fluid/Blood Leak	2	2
Contamination /Decontamination Problem	2	2
Failure to Deliver	2	2
Excess Flow or Over-Infusion	2	2
No Flow	2	3
Gas Output Problem	2	2
Infusion or Flow Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Sharp Edges	2	2
Material Deformation	2	2
Tear, Rip or Hole in Device Packaging	2	2
Tidal Volume Fluctuations	2	3
Temperature Problem	1	1
Inadequate Filtration Process	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	226	227
Low Oxygen Saturation	34	35
Insufficient Information	27	27
No Consequences Or Impact To Patient	8	8
Respiratory Arrest	3	3
Diminished Pulse Pressure	3	3
Cardiac Arrest	3	3
Dyspnea	3	3
Bradycardia	3	4
Cough	3	4
Hypoxia	3	3
Unspecified Respiratory Problem	3	3
Airway Obstruction	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Hypoventilation	2	2
Aspiration/Inhalation	2	2
Respiratory Insufficiency	2	2
Ventilator Dependent	2	2
Cyanosis	1	1
High Blood Pressure/ Hypertension	1	2
Apnea	1	1
Brain Injury	1	1
Abrasion	1	1
Obstruction/Occlusion	1	1
Cardiopulmonary Arrest	1	1
Capsular Contracture	1	1
Pulmonary Edema	1	2
Bronchospasm	1	1
Unspecified Tissue Injury	1	1
Hemorrhage/Bleeding	1	1
Distress	1	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Covidien, LP	II	Jun-16-2021
2	Draeger Medical, Inc.	I	Jun-10-2022
3	Draeger, Inc.	I	Jul-31-2025
4	Kung Shin Plastics Co. Ltd.	II	Mar-04-2025
5	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
6	Medline Industries, LP	I	Nov-13-2025
7	S & MOHR AMERICA, S.A. DE C.V.	III	Feb-22-2023
8	Smiths Medical ASD Inc.	II	Aug-28-2023
9	TELEFLEX LLC	I	Oct-14-2022