Medical device recalls reported in 2019

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Reported	Recall	Class	Product	Firm
2019-11-13	Z-0284-2020	Class II	MaxZero Extension Sets with Needle-less Connector	Becton Dickinson & Company
2019-11-13	Z-0285-2020	Class II	13 Fr	Becton Dickinson & Company
2019-11-13	Z-0286-2020	Class III	Hemo-Drop Blood Dispenser	Biomedical Polymers, Inc.
2019-11-13	Z-0287-2020	Class III	Manual Diff Dropper	Biomedical Polymers, Inc.
2019-11-13	Z-0288-2020	Class II	(1) Argon Medical Devices Double Female LL Adapter, Special Adapter…	Argon Medical Devices, Inc
2019-11-13	Z-0289-2020	Class II	Argon Medical Devices Double Male LL Adapter	Argon Medical Devices, Inc
2019-11-13	Z-0290-2020	Class II	(1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer…	Argon Medical Devices, Inc
2019-11-13	Z-0291-2020	Class II	Argon Medical Devices TRI-JECT	Argon Medical Devices, Inc
2019-11-13	Z-0292-2020	Class II	Argon Medical Devices Plugs	Argon Medical Devices, Inc
2019-11-13	Z-0293-2020	Class II	(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp,…	Argon Medical Devices, Inc
2019-11-13	Z-0294-2020	Class II	Argon Medical Devices Hemostasis Valve	Argon Medical Devices, Inc
2019-11-13	Z-0295-2020	Class II	Argon Medical Devices Septishield II	Argon Medical Devices, Inc
2019-11-13	Z-0296-2020	Class II	Argon Medical Devices AHD Luer Lock Cap	Argon Medical Devices, Inc
2019-11-13	Z-0297-2020	Class III	SPIFE Alkaline Hemoglobin Kit	Helena Laboratories, Corp.
2019-11-13	Z-0298-2020	Class II	BF Humeral Stem	Zimmer Biomet, Inc.
2019-11-13	Z-0299-2020	Class II	Trabecular Metal Reverse Shoulder System	Zimmer Biomet, Inc.
2019-11-13	Z-0300-2020	Class II	Sidus Stem-Free Shoulder Humeral Head	Zimmer Biomet, Inc.
2019-11-13	Z-0301-2020	Class II	Coorad Morrey Total Elbow	Zimmer Biomet, Inc.
2019-11-13	Z-0302-2020	Class II	Various Custom Devices	Zimmer Biomet, Inc.
2019-11-13	Z-0303-2020	Class II	NCB Proximal Lateral Tibia	Zimmer Biomet, Inc.
2019-11-13	Z-0304-2020	Class II	NCB PERIPROSTHETIC	Zimmer Biomet, Inc.
2019-11-13	Z-0305-2020	Class II	ZPLP Fibular Plate	Zimmer Biomet, Inc.
2019-11-13	Z-0306-2020	Class II	TM Ankle and Ankle Talus L/R	Zimmer Biomet, Inc.
2019-11-13	Z-0307-2020	Class II	Periarticular Plates	Zimmer Biomet, Inc.
2019-11-13	Z-0308-2020	Class II	PERIARTICULAR PLATES	Zimmer Biomet, Inc.
2019-11-13	Z-0309-2020	Class II	Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos	Zimmer Biomet, Inc.
2019-11-13	Z-0310-2020	Class II	DIST LAT FEM LCK PLATE STERILE	Zimmer Biomet, Inc.
2019-11-13	Z-0311-2020	Class II	SM DIS VOL/DORS RAD LAT COL PLATE	Zimmer Biomet, Inc.
2019-11-13	Z-0312-2020	Class II	Universal Locking Plates Sterile	Zimmer Biomet, Inc.
2019-11-13	Z-0313-2020	Class II	PERIARTICULAR PLATES SHOULDER	Zimmer Biomet, Inc.
2019-11-13	Z-0314-2020	Class II	Periarticulare Plates	Zimmer Biomet, Inc.
2019-11-13	Z-0315-2020	Class II	PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL	Zimmer Biomet, Inc.
2019-11-13	Z-0316-2020	Class II	PROX LAT HUMERAL LOCK PLATE	Zimmer Biomet, Inc.
2019-11-13	Z-0317-2020	Class II	Periarticular locking plate elbow-sterile	Zimmer Biomet, Inc.
2019-11-13	Z-0318-2020	Class II	Various Hip Joint Replacement Systems	Zimmer Biomet, Inc.
2019-11-13	Z-0319-2020	Class II	CLS Brevius Stem Kinectiv	Zimmer Biomet, Inc.
2019-11-13	Z-0320-2020	Class II	Fitmore Hip Stem	Zimmer Biomet, Inc.
2019-11-13	Z-0321-2020	Class II	Various Knee Systems for knee joint arthroplasty	Zimmer Biomet, Inc.
2019-11-13	Z-0322-2020	Class II	Various Surgical Instruments: Screws and Reamers	Zimmer Biomet, Inc.
2019-11-13	Z-0323-2020	Class II	Various Devices for Limb salvage arthroplasty	Zimmer Biomet, Inc.
2019-11-13	Z-0324-2020	Class II	LPS-MOB ART SURF IMPL D 9MM	Zimmer Biomet, Inc.
2019-11-13	Z-0325-2020	Class II	Various Knee Systems	Zimmer Biomet, Inc.
2019-11-13	Z-0326-2020	Class II	Various fixation systems and accessories	Zimmer Biomet, Inc.
2019-11-13	Z-0327-2020	Class II	CABLE-READY SHORT GTR and CABLE-READY LONG GTR	Zimmer Biomet, Inc.
2019-11-13	Z-0328-2020	Class II	Various fixation systems and accessories	Zimmer Biomet, Inc.
2019-11-13	Z-0329-2020	Class II	Various temporary devices used during the implantation of the device…	Zimmer Biomet, Inc.
2019-11-13	Z-0330-2020	Class II	Connection Screw for NCB Plate	Zimmer Biomet, Inc.
2019-11-13	Z-0331-2020	Class II	NCB Straight Narrow Plate	Zimmer Biomet, Inc.
2019-11-13	Z-0332-2020	Class II	NCB-PH Plate with 4/5/7 Lock Holes	Zimmer Biomet, Inc.
2019-11-13	Z-0333-2020	Class II	FEMOROTIBIAL/FEMORAL NAIL	Zimmer Biomet, Inc.
2019-11-13	Z-0334-2020	Class II	Metasul Taper Liner	Zimmer Biomet, Inc.
2019-11-13	Z-0335-2020	Class II	Metasul Femoral Heads	Zimmer Biomet, Inc.
2019-11-13	Z-0336-2020	Class II	Ceramic Femoral Heads	Zimmer Biomet, Inc.
2019-11-13	Z-0337-2020	Class II	Cephalomedullary Nail	Zimmer Biomet, Inc.
2019-11-13	Z-0338-2020	Class II	cable button for NCB¿ Polyaxial Locking Plate	Zimmer Biomet, Inc.
2019-11-13	Z-0339-2020	Class II	Grab n Go Opti series VIPR system Model # PRX-9615	Western / Scott Fetzer Company
2019-11-13	Z-0340-2020	Class II	Grab n Go Opti series VIPR system Model # PRX-9627	Western / Scott Fetzer Company
2019-11-13	Z-0341-2020	Class II	Grab n Go Opti series VIPR system Model # PRX-9632	Western / Scott Fetzer Company
2019-11-13	Z-0342-2020	Class II	Grab n Go Opti series VIPR system Model # PRX-9646	Western / Scott Fetzer Company
2019-11-13	Z-0343-2020	Class II	Grab n Go Opti series VIPR system Model # PRX-9653	Western / Scott Fetzer Company
2019-11-13	Z-0344-2020	Class II	Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT	Centurion Medical Products Corporation
2019-11-13	Z-0345-2020	Class II	lmpella CP with Smart Assist	Abiomed, Inc.
2019-11-13	Z-0346-2020	Class II	The LivaNova VNS Therapy System	LivaNova USA Inc
2019-11-13	Z-0347-2020	Class II	Omnipod DASH Insulin Management System	Insulet Corporation
2019-11-06	Z-0194-2020	Class II	Posey Connected Twice-As-Tough Cuffs	TIDI PRODUCTS
2019-11-06	Z-0195-2020	Class II	DEMO No Needle Corrugated Carton 20 U/D	Valeritas, Incorporated
2019-11-06	Z-0196-2020	Class II	DEMO No Needle Corrugated Carton 30 U/D	Valeritas, Incorporated
2019-11-06	Z-0197-2020	Class II	DEMO No Needle Corrugated Carton 40 U/D	Valeritas, Incorporated
2019-11-06	Z-0198-2020	Class II	DEMO No Needle Corrugated Carton 20 U/D	Valeritas, Incorporated
2019-11-06	Z-0199-2020	Class II	DEMO No Needle Corrugated Carton 30 U/D	Valeritas, Incorporated
2019-11-06	Z-0200-2020	Class I	ECHELON FLEX ENDOPATH 60mm Stapler	Ethicon Endo-Surgery Inc
2019-11-06	Z-0201-2020	Class I	ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler	Ethicon Endo-Surgery Inc
2019-11-06	Z-0202-2020	Class I	ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler	Ethicon Endo-Surgery Inc
2019-11-06	Z-0203-2020	Class I	ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler	Ethicon Endo-Surgery Inc
2019-11-06	Z-0218-2020	Class II	Model No	OrthoPediatrics Corp
2019-11-06	Z-0219-2020	Class II	Model No	OrthoPediatrics Corp
2019-11-06	Z-0220-2020	Class II	SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of…	LivaNova USA Inc.
2019-11-06	Z-0221-2020	Class I	CentriMag Acute Circulatory Support System Motor	Thoratec Switzerland GMBH
2019-11-06	Z-0222-2020	Class II	C3 Wave App	Medical Components, Inc dba MedComp
2019-11-06	Z-0223-2020	Class II	Synapse System 3	Synthes (USA) Products LLC
2019-11-06	Z-0224-2020	Class II	HYTEC Stop Solution	Hycor Biomedical LLC
2019-11-06	Z-0225-2020	Class II	Synchro2	Stryker Neurovascular
2019-11-06	Z-0226-2020	Class II	Synchro2	Stryker Neurovascular
2019-11-06	Z-0227-2020	Class II	Synchro2	Stryker Neurovascular
2019-11-06	Z-0228-2020	Class II	Synchro2	Stryker Neurovascular
2019-11-06	Z-0229-2020	Class II	Synchro2	Stryker Neurovascular
2019-11-06	Z-0230-2020	Class II	Synchro2	Stryker Neurovascular
2019-11-06	Z-0231-2020	Class II	Synchro2	Stryker Neurovascular
2019-11-06	Z-0232-2020	Class II	Synchro2	Stryker Neurovascular
2019-11-06	Z-0233-2020	Class II	Convex Two-Piece Ostomy System	ConvaTec, Inc
2019-11-06	Z-0234-2020	Class II	SPROTTE Lumbar with Introducer	Pajunk GmbH
2019-11-06	Z-0235-2020	Class II	Accutorr 3 Vital Signs Monitor with NIBP valve assembly board	Mindray DS USA, Inc. dba Mindray North America
2019-11-06	Z-0236-2020	Class II	Accutorr 7 Vital Signs Monitor with NIBP valve assembly board	Mindray DS USA, Inc. dba Mindray North America
2019-11-06	Z-0237-2020	Class II	Rosie4 Vital Signs Monitor with NIBP valve assembly board	Mindray DS USA, Inc. dba Mindray North America
2019-11-06	Z-0238-2020	Class II	Rosebud Vital Signs Monitor with NIBP valve assembly board	Mindray DS USA, Inc. dba Mindray North America
2019-11-06	Z-0239-2020	Class II	Programmers & Remote Monitoring Software Apps: 2090 CareLink…	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2019-11-06	Z-0240-2020	Class II	Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore…	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2019-11-06	Z-0241-2020	Class II	Programmers & Remote Monitoring Software Apps: CareLink SmartSync…	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2019-11-06	Z-0242-2020	Class II	A&E Medical Thorecon Plating System Kits Model No	Alto Development Corp
2019-11-06	Z-0243-2020	Class II	A&E Medical Thorecon Plating System Kits Model No	Alto Development Corp
2019-11-06	Z-0244-2020	Class II	A&E Medical Thorecon Plating System Kits Model No	Alto Development Corp
2019-11-06	Z-0245-2020	Class II	A&E Medical Thorecon Plating System Kits Model No	Alto Development Corp
2019-11-06	Z-0246-2020	Class II	A&E Medical Thorecon Plating System Kits Model No	Alto Development Corp
2019-11-06	Z-0247-2020	Class II	TherMax Blood Warmer Unit	Baxter Healthcare Corporation
2019-11-06	Z-0248-2020	Class II	SAROS Oxygen System Model 3000	Caire, Inc.
2019-11-06	Z-0249-2020	Class II	EndoWrist Suction Irrigator	Intuitive Surgical, Inc.
2019-11-06	Z-0250-2020	Class II	Cordis MAXI LD PTA Dilatation Catheter	Cordis Corporation
2019-11-06	Z-0251-2020	Class II	Eversense CGM SENSOR	Senseonics, Inc.
2019-11-06	Z-0252-2020	Class II	BD Vacutainer Eclipse Blood Collection Needles 22Gx1	Becton Dickinson & Company
2019-11-06	Z-0253-2020	Class II	Port full Access Tray Product Code: DT19330	Centurion Medical Products Corporation
2019-11-06	Z-0254-2020	Class II	Maintenance Flush Kit/Blood Draw Product Code: DT19335	Centurion Medical Products Corporation
2019-11-06	Z-0255-2020	Class II	Kit	Centurion Medical Products Corporation
2019-11-06	Z-0256-2020	Class II	PORT ACCESS INFUSION KIT	Centurion Medical Products Corporation
2019-11-06	Z-0257-2020	Class II	CardioLab/ComboLab Recording Systems	GE Healthcare, LLC
2019-11-06	Z-0258-2020	Class II	The Infinity Acute Care System	Draegar Medical Systems, Inc.
2019-11-06	Z-0259-2020	Class II	Various products which were contract sterilized	Anewmed Corporation
2019-11-06	Z-0260-2020	Class II	Dario Blood Glucose Monitoring System	LABSTYLE INNOVATIONS
2019-11-06	Z-0261-2020	Class II	Implant Direct Scan Adapter Assembly Replant platform for the…	Implant Direct Sybron Manufacturing, LLC
2019-11-06	Z-0262-2020	Class II	POM Procedural Oxygen Masks	POM Medical LLC
2019-10-30	Z-0160-2020	Class II	Mammomat Revelation with software version VC10 and Biopsy Option…	Siemens Medical Solutions USA, Inc
2019-10-30	Z-0161-2020	Class II	xTAG Respiratory Viral Panel	Luminex Molecular Diagnostics
2019-10-30	Z-0162-2020	Class III	OptiLITE	Xintec Corp
2019-10-30	Z-0163-2020	Class II	IMRIS MR/X-ray head fixation device	Deerfield Imaging, Inc.
2019-10-30	Z-0164-2020	Class II	Rifton TRAM Standard Base	Community Products, LLC
2019-10-30	Z-0165-2020	Class II	Rifton TRAM Low Base	Community Products, LLC
2019-10-30	Z-0166-2020	Class II	Rifton E-Pacer	Community Products, LLC
2019-10-30	Z-0167-2020	Class II	EXACTAMIX Empty EVA	Baxter Healthcare Corporation
2019-10-30	Z-0168-2020	Class II	Ergo 3	Exactech, Inc.
2019-10-30	Z-0169-2020	Class II	OMNI Hip System Model	OMNIlife science Inc.
2019-10-30	Z-0170-2020	Class II	The ICS CHARTR EP 200	GN Otometrics
2019-10-30	Z-0171-2020	Class II	Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module	ICU Medical Inc
2019-10-30	Z-0173-2020	Class II	Emerald Diluent Tubing	Abbott Laboratories
2019-10-30	Z-0174-2020	Class II	Semi-Rigid Suction Canister	Medline Industries Inc
2019-10-30	Z-0175-2020	Class II	ApexPro Telemetry Server System	GE Healthcare, LLC
2019-10-30	Z-0176-2020	Class II	Patient Data Manager	Brainlab AG
2019-10-30	Z-0179-2020	Class II	Sterile Co-Flex NL 3"	Andover Healthcare Inc.
2019-10-30	Z-0180-2020	Class II	Sterile Co-Flex NL 4"	Andover Healthcare Inc.
2019-10-30	Z-0181-2020	Class II	Sterile Co-Flex LF2 3"	Andover Healthcare Inc.
2019-10-30	Z-0182-2020	Class II	Sterile Co-Flex LF2 4"	Andover Healthcare Inc.
2019-10-30	Z-0183-2020	Class II	Sterile Co-Flex Med 3"	Andover Healthcare Inc.
2019-10-30	Z-0184-2020	Class II	Sterile Co-Flex Med 4"	Andover Healthcare Inc.
2019-10-30	Z-0185-2020	Class II	Torrent Suite Dx Software Version	Life Technologies Holdings Pte Ltd
2019-10-30	Z-0186-2020	Class II	Torrent Suite Dx Software Version	Life Technologies Holdings Pte Ltd
2019-10-30	Z-0187-2020	Class II	Torrent Suite Dx Software Version 5	Life Technologies Holdings Pte Ltd
2019-10-30	Z-0188-2020	Class II	Torrent Suite Dx Software Version 5	Life Technologies Holdings Pte Ltd
2019-10-30	Z-0189-2020	Class II	GRIPPER Needles sold individually	Smiths Medical ASD Inc.
2019-10-30	Z-0190-2020	Class II	GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM	Smiths Medical ASD Inc.
2019-10-30	Z-0191-2020	Class II	Irrisept Wound Debridement and Cleansing System	IrriMAX Corporation
2019-10-30	Z-0192-2020	Class II	Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to…	Arrow International Inc
2019-10-30	Z-0193-2020	Class II	BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached…	Becton Dickinson & Company
2019-10-30	Z-0204-2020	Class II	Atellica IM 1300 Analyzer	Siemens Healthcare Diagnostics, Inc.
2019-10-30	Z-0205-2020	Class II	Atellica IM 1600 Analyzer	Siemens Healthcare Diagnostics, Inc.
2019-10-30	Z-0206-2020	Class II	Canister HFC-134a /1000g	Candela Corporation
2019-10-30	Z-0207-2020	Class II	Canister HFC-134a /1000g	Candela Corporation
2019-10-30	Z-0208-2020	Class II	Canister HFC-134a / 980g	Candela Corporation
2019-10-30	Z-0209-2020	Class II	Canister HFC-134a /980g	Candela Corporation
2019-10-30	Z-0210-2020	Class II	Beckman Coulter Lipase	Beckman Coulter Inc.
2019-10-30	Z-0211-2020	Class II	Beckman Coulter Uric Acid	Beckman Coulter Inc.
2019-10-30	Z-0212-2020	Class II	MotoBand CP	CrossRoads Extremity Systems, LLC
2019-10-23	Z-0122-2020	Class II	Euphoria Rapid Exchange Balloon Dilatation Catheter	Medtronic Vascular Galway DBA Medtronic Ireland
2019-10-23	Z-0123-2020	Class II	Solarice Rapid Exchange Balloon Dilatation Catheter	Medtronic Vascular Galway DBA Medtronic Ireland
2019-10-23	Z-0124-2020	Class II	Cerelink ICP Monitor	Integra LifeSciences Corp.
2019-10-23	Z-0125-2020	Class II	OrthoPediatrics Adolescent attachment bolt used with the Pediatric…	OrthoPediatrics Corp
2019-10-23	Z-0126-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0127-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0128-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0129-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0130-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0131-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0132-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0133-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0134-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0135-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0136-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0137-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0138-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0139-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0140-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0141-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0142-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0143-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0144-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0145-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0146-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0147-2020	Class II	Infusion Pump I	ICU Medical Inc
2019-10-23	Z-0148-2020	Class II	Siemens Atellica CH 930 Analyzer	Siemens Healthcare Diagnostics, Inc.
2019-10-23	Z-0149-2020	Class II	Electrosurgical Tip Cleaner REF: 138029 Product Usage:…	Xodus Medical Inc
2019-10-23	Z-0150-2020	Class II	Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage:…	Xodus Medical Inc
2019-10-23	Z-0151-2020	Class II	Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical…	Xodus Medical Inc
2019-10-23	Z-0152-2020	Class III	Roche Diagnostics cobas Integra Albumin Gen	Roche Diagnostics Operations, Inc.
2019-10-23	Z-0153-2020	Class III	Cobas c Bilirubin Total Gen	Roche Diagnostics Operations, Inc.
2019-10-23	Z-0154-2020	Class II	Viva	Vital Scientific N.V.
2019-10-23	Z-0155-2020	Class II	Viva-E	Vital Scientific N.V.
2019-10-23	Z-0156-2020	Class II	V-Twin	Vital Scientific N.V.
2019-10-23	Z-0157-2020	Class II	Selectra ProM Analyzer	Vital Scientific N.V.
2019-10-23	Z-0158-2020	Class II	Selectra ProS Analyzer	Vital Scientific N.V.
2019-10-23	Z-0159-2020	Class II	Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage…	Olympus Corporation of the Americas
2019-10-16	Z-0038-2020	Class II	V-Twin	Vital Scientific N.V.
2019-10-16	Z-0039-2020	Class II	BioEnvelope	AZIYO BIOLOGICS
2019-10-16	Z-0040-2020	Class II	CanGaroo Envelopes labeled as the following: 1	AZIYO BIOLOGICS

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