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IPAC Canada Alerts, Recalls and Advisories

Updates on product alerts, recalls, advisories from the Canadian Food Inspection Agency (CFIA, Health Canada and the Health Product InfoWatch. Recalls and safety alerts are sent out when there is important information to share regarding products.

2023

May 17: Listeria monocytogenes in enoki mushrooms (ON) RECALL
May 13: Montelukast chewable tablet; Out of specification
May 12: Heparin sodium in 5% Dextrose injection; Out of specification
May 11: Shortage of Nitroglycerin Sprays and Tablets in Canada
May 9: Emerade injection; Device failure
May 6: Solarcaine first aid spray; Labelling issue
May 6: 0.9% Sodium chloride inj; Bags leaking
May 6: SM Nutrition Saffron Extract Max; Labelling issue
May 6: Single Use Distal Cover
May 6: Cemvac System – Nozzles
May 6: Bioknotless Br Anchor With Orthocord
May 5: Medline Surgery Packs
May 5: Stealthstation S7 – Software, Cranial
May 5: Bausch Health, Canada Inc. recalls all lots of Emerade epinephrine auto-injectors (0.3 mg and 0.5 mg strengths) due to possible device failure
May 3: Salmonella in curly parsley (QC) RECALL
Apr 1: Philips Azurion System
Apr 1: Magnesium Oxide 420 mg: The dissolution is out of specification in the affected lot.
Mar 25: Sterile Light Handle Cover
Mar 25: Monnal T60
Mar 24: Hamilton C6 Intensive Care Ventilator
Mar 24: Vacuette * K2 EDTA
Mar 23: Infinity® Central Station
Mar 23: Arjo Portable Scale Adaptor
Mar 23: Rayplan and Raystation
Mar 22: Clostridium botulinum in carob drink (ON, QC, NS) RECALL
Mar 19: Two lots of cystic fibrosis drug Cayston recalled due to the potential of cracked glass vials
Mar 18: Cronobacter sakazakii in infant formula (Canada-wide) RECALL
Mar 18: Surgical Gut – Plain and Absorbable Sutures
Mar 18: Disposable Rotatable Clip Fixing Device
Mar 18: Heater-Cooler Unit HCU 40
Mar 17: Shortage of Nitroglycerin Sprays in Canada
Mar 17: Cardiosave System – Hybrid & Rescue Intra-Aortic Balloon Pump
Mar 17: Robikids and Solmux are unauthorized children’s syrups for thinning mucus and may pose serious health risks
Mar 17: Aqure System
Mar 17: Habib™ EndoHPB Catheter
Mar 16: BD Bodyguard Microset
Mar 16: CT Scan and High Capacity Table
Mar 16: Cannulated Screw System
Mar 16: Durasul Modular Head
Mar 16: Express Mini 500 and Pneumostat Chest Drain Valve
Mar 11: Eyecee One Preloaded
Mar 11: Capiox FX25 Hollow Fiber Oxygenator With Integrated Arterial Filter
Mar 11: Safelight Fiber Optic Cable Clear, 5mm X 10ft 3.05m
Mar 11: Bard Mission Disposable Core Biopsy Instrument Kit
Mar 11: Tempus Pro
Mar 10: Injetak Adjustable Tip Needle
Mar 10: Bioplex 2200 Anti-CCP System
Mar 10: Da Vinci Surgical Systems
Mar 10: Capiox Fx15 Hollow Fiber Oxygenator With Integrated Arterial Filter
Mar 9: Tantalum Bead 1.00mm
Mar 9: ACL Elite Coagulation Analyzers
Mar 3: Monaco
Mar 3: CAYSTON: Vials may be cracked in affected lots
Mar 3: Attune System – Tibial Insert Fixed Bearing Posterior Stabilized
Mar 3: Smartperfusion and 2D perfusion
Mar 3: Unauthorized health products from Kausch International Goods may pose serious health risks
Mar 3: Probiotic Blister: Out of Specification
Mar 3: ProbioMax 50 Billion: Out of Specification
Mar 3: Amicus Exchange and Mononuclear Cell Apheresis Kits
Mar 2: Pommel Walker (Senior, Junior, Mini)
Mar 2: Grafton and Grafton Plus Demineralized Bone Matrix
Mar 2: Infinity Occipitocervical Upper Thoracic System Multi Axial Screw
Feb 25:Cardiomems Hospital Electronics System
Feb 25: Smartpill Smartbar
Feb 25: Freestyle Libre 2 App (Android)
Feb 25: Luminos, Uroskop and Axiom Systems
Feb 25: Vital Vision Plus Omega 3: Incorrect label for pediatric subpopulation
Feb 25: Lo-Pro Tracheal Tube Cuffed Murphy Tip
Feb 24: Cardiomems Patient and Hospital Electronics System
Feb 23: Centricity High Acuity Anesthesia
Feb 23: Tantalum Bead 1.00mm
Feb 23: Tracoe Experc Sets
Feb 21: Listeria monocytogenes in cheese fondue (AB, QC) RECALL
Feb 20: Listeria monocytogenes in cheese fondue (QC, ON, BC, AB, NS) RECALL
Feb 18: Listeria monocytogenes in cheddar cheese (ON) RECALL
Feb 18: BD Insulin Syringes With The BD Micro-Fine IV Needle
Feb 18: Cardiosave System – Hybrid & Rescue Intra-Aortic Balloon Pump
Feb 18: Ballard Oral Care Swab
Feb 17: Listeria monocytogenes in in cheddar cheese (Canada-wide) RECALL
Feb 17: Freestyle Libre Sensor Kits
Feb 17: Delfia Inducer
Feb 17: Transport Strut Hoffmann Lrf
Feb 17: Vital Vision Plus Omega 3: Incorrect label for pediatric subpopulation
Feb 16: ZEJULA (niraparib) - Update on the Maintenance Treatment in Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in the Second or Later Line Setting
Feb 15: Listeria monocytogenes in cheese (ON, QC) RECALL
Feb 15: Cholester-Aid: Reported adverse reactions
Feb 15: AG-BISOPROLOL: Foreign matter
Feb 14: Acetaminophen Tablets 500 mg: The dissolution is out of specification in the affected lot.
Feb 14: Jamp-Calcium + Vitamin D 1000 IU: Presence of foreign matter in affected lot.
Feb 12: Listeria monocytogenes in raw milk cheddar cheese (ON, QC) RECALL
Feb 11: Quanta Flash Gbm Calibrators
Feb 11: Artis Pheno
Feb 10: Simplexa Covid-19 & Flu A/B Direct
Feb 10: Heartsine Samaritan Pad 500P
Feb 9: Wearable Breast Pumps
Feb 9: Anesthesia Set Flex, Latex Free, Us
Feb 9: Tri-Staple™ 2.0 Black Intelligent Reload
Feb 9: Minicap Disconnect Cap With Povidone-Iodine
Feb 8: Medline 3" Walker Wheels With Glide Caps
Feb 8: Aquacel Ag Foam Dressing, Adhesive
Feb 8: 2D/3D Mammography Systems
Feb 2: Novum IQ Large Volume Pump
Feb 2: Cronobacter in fiber plus powder (Canada-wide) RECALL
Feb 2: Hemashield Gold Knitted Graft
Feb 1: Hager & Meisinger GmbH Micro Screw
Feb 1: Celestone Soluspan: Affected lots may contain the presence of foreign matter.
Feb 1: Elecsys® Troponin T Hs
Feb 1: Access 2 Immunoassay Analyzer
Jan 27: Beaver Edgeahead Stiletto/Mvr Knife 0.90mm Straight (20g)
Jan 27: Flowtriever Retrieval/Aspiration Syste
Jan 27:Nasal Septal Button, 5-Cm
Jan 26: Cardinal Health™ Jackson-Pratt™ channel drains
Jan 26: Statis Dental Handpieces
Jan 25: Novastar Full Face Mask
Jan 25: Mas CardioImmune Xl 1 2 3, Mas CardioImmune Xl L
Jan 21: RUZURGI (amifampridine) – Removal from Canadian Market: Options for Continued Treatment for Lambert-Eaton Myasthenic Syndrome
Jan 20: Hager & Meisinger GmbH Micro Screw
Jan 20: Belzer MPS and Belzer UW: Particulate matter
Jan 20: Hickman And Leonard Lumen CV Catheters
Jan 20: Nuzone X2 Synthetic Polychloroprene Sterile Surgical Gloves Powder Free
Jan 19: Novaguide Intelligent Ultrasound System
Jan 19: Visiusmatrix 4.0
Jan 18: EVUSHELD (tixagevimab and cilgavimab for injection) – Risk of Prophylaxis or Treatment Failure due to Antiviral Resistance to specific SARS-CoV-2 Subvariants
Jan 18: Permanent Life Support and HLS Sets
Jan 17: Somatom X.Cite
Jan 14: Listeria monocytogenes in semi-soft surface-ripened cheese (QC) RECALL
Jan 14: Digital TENS/EMS
Jan 14: Medline Custom Procedure Packs – Non-absorbable sutures
Jan 14: Cannula, Neonate, Oxygen W/3-Channel Tube 7' – 50/Cs
Jan 6: Biostop G Bioresorbable Cement Restrictor
Jan 6: Immulite 2000 Sytstem Thyroglobulin Assay
Jan 6: Covera™ Vascular Covered Stent
Jan 6: Kit Cobas 6800/8800 Sars-Cov-2/Flu
Jan 5: Cardiosave System – Hybrid & Rescue Intra-Aortic Balloon Pump
Jan 5: Prehma Disposable Dental Needles
Jan 5: Ortho Vision Analyzers
Jan 5: Affinity Fusion Oxygenators
Jan 4: Craniotome
Jan 4: Artis Q and Zee Systems
Jan 4: Artis Icono and Pheno Systems
Jan 4: Magnetom Systems

Archived Alerts, Recalls and Advisories

2022

Dec 31: Nuclear Medicine Systems
Dec 31: Luminos Agile Max
Dec 31: Orise Gel Pack and Procedure Kit
Dec 31: Cardinal Health™ Channel Wound Drains
Dec 25: Immulite 2000 Sytstem Thyroglobulin Assay
Dec 25: Cobas Infinity Central Lab
Dec 25: Epoc Blood Analysis System
Dec 25: Luminos And Axiom Footrests
Dec 24:BC-3600 Auto Hematology Analyzer – BC-3D Hematology Control
Dec 24: Mahurkar Acute Dual Lumen Catheter Kits
Dec 24: Nexgen Complete Knee Solution Stemmed Non-Augment Tibial Comp (Cr/Ps) Option
Dec 24: Airo Mobile Ct System
Dec 24: Cadd Medication Cassette Reservior
Dec 24: Teleflex Stylet, Endotracheal Kit and Flexi-Set
Dec 24: Alinity M System
Dec 22: RegenKit® BCT-3
Dec 22: Stradis Implant Packs
Dec 22: Trilogy Ventilators
Dec 22: Vanta/Sequentia Lt Clinician Programmer Application
Dec 22: Cadd Administration Set
Dec 18: Heartware Ventricular Assist System – HVAD Implant Kit
Dec 18: 3T MRI Systems
Dec 18: Guarded Luer Connector
Dec 17: Leukosure Enumeration Kit
Dec 17: Criticool Control Unit
Dec 17: Medline Packs
Dec 17: Heartstart Defibrillation Pads
Dec 17: Fetal Spiral Electrode
Dec 15: Allergenic extract non pollens (Peanut allergy): False negative for skin test
Dec 15: 18F-Fludeoxyglucose (18F-FDG); Sterility concerns
Dec 15: Ortho Connect
Dec 15: Med-Rx Universal Anesthesia Kits
Dec 15: VENTANA PD-L1 (SP142)
Dec 15: Alinity M Resp-4-Plex Amplification (Amp) Kit (Ce)
Dec 15: Battery Mobile X-Ray Systems Soltus
Dec 14: Evolut Pro+ Transcatheter Aortic Valve
Dec 14: Oncentra Brachy
Dec 9: COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels: New Formulation for Use in Children Aged 5 Years to Less Than 12 Years
Dec 5: OCALIVA (obeticholic acid) – New Contraindication for the Treatment of Primary Biliary Cholangitis (PBC)
Dec 3: Chocolate II Agar
Dec 3: Revaclear 400 Dialyzer; Revaclear 300 Dialyzer
Dec 3: BD Alaris Large Volume Pump
Dec 3: Sensis Vibe
Dec 2: Tracoe Experc Percut Dilation Sets
Nov 27: PDS (Polydioxanone) Monofilament Suture
Nov 26: Ortho Optix™ Reader
Nov 26: Power-Pro 2
Nov 26: T2100 Treadmill
Nov 26: Aquac Uno H Reverse Osmosis System – Main Unit
Nov 26: Irispec Ca/Cb/Cc
Nov 25: Jamshidi Bone Marrow Biopsy/Aspiration Needle
Nov 25: Magec 2 Device
Nov 25: 3M™ Steri-Drape™ Surgical Drapes Packs
Nov 25:Autocat 2 Systems
Nov 25: Vivid Ultrasound Systems
Nov 25: Modified Saf Transport
Nov 20: Bipolar Forceps
Nov 20: SPIKEVAX Bivalent (Original / Omicron BA.4/5) (elasomeran/davesomeran) COVID-19 Vaccine with English-only Vial and Carton Labels
Nov 19: Single Use Oats Set
Nov 18: Permanent Life Support Set
Nov 18: Easystand Bantam
Nov 17: Trackmaster Treadmills
Nov 17: Ranger Blood/Fluid Warming Systems
Nov 14: Safety Cartridge Sterile
Nov 14: Children’s ibuprofen/acetaminophen shortage: What you should know and do
Nov 11: Enduracharge 36v Li-Ion Battery
Nov 11: Pinnacle and Cirrus Ceiling Lift
Nov 11: Progressa (Frame)
Nov 11: Lifeport Adapters and Patient Circuit Kits
Nov 11: Ophthalmic Surgery Procedure Pack (new)
Nov 10: Emblem MRI S-ICD PG
Nov 10: Liberator Stationary Liquid Oxygen Device
Nov 10: Fotofinder ATBM Master
Nov 10: Neo-Fit Neonatal Endotracheal Tube Grip
Nov 3: Med-Rx Extension Set
Nov 3: Extension Table Top
Nov 2: Da Vinci Xi/X Sureform 45/60 Stapler
Oct 31: Janus Kinase Inhibitors and the Risk of Major Adverse Cardiovascular Events, Thrombosis (Including Fatal Events) and Malignancy
Oct 27: Personal Diabetes Manager Kit
Oct 26: Wireless Fetal Monitoring System
Oct 26: Chemistry Products Calibrator
Oct 26: Procedure and Gel Syringe Kits
Oct 26: EVUSHELD (tixagevimab and cilgavimab for injection) - Risk of Prophylaxis or Treatment Failure due to Antiviral Resistance
Oct 26: Large Volume Pump (LVP)
Oct 24: Potassium Chloride in Lactated Ringers' Injection: Affected lot is labelled with the incorrect strength and ingredient
Oct 19: Surgical Drapes
Oct 19: X-Guide X-Mark Probe Tool
Oct 14: Ortho Vision Analyzers
Oct 14: Fluid Control System
Oct 14: V-Loc PBT Non-Absorbable/180 Absorbable Devices
Oct 7: COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels
Oct 7: BOOSTRIX: Syringes may be cracked in affected lot
Oct 3: Double Swivel Closed Suction Catheter
Sep 28: BD Vacutainer Tube Sodium Fluoride/Potassium Oxalate
Sep 23: Leica Microsystems M530 Optics Carrier
Sep 23: Anaesthesiology masks
Sep 23: Mitraclip/Triclip G4 Delivery Systems
Sep 20: Flexible Cystoscope
Sep 20: Anti-GM1 Autoantibodies Elisa IVD Test
Sep 20: Heat And Moisture Exchanger (HME) And Filters
Sep 20: Smallbore T-Port Extension Set
Sep 12: ZOLGENSMA (onasemnogene abeparvovec) and Fatal Cases of Acute Liver Failure
Sep 12: Health Canada warns about certain hand sanitizers that may pose health risks
Sep 9: COMIRNATY (COVID-19 Vaccine, mRNA, also referred to as Pfizer-BioNTech COVID-19 Vaccine): New Presentation for Use in Children Aged 6 Months to Less Than 5 Years with English-only Vial and Carton Labels
Sep 2: Distribution of SPIKEVAX Bivalent (elasomeran/imelasomeran) COVID-19 Vaccine with English-only Vial and Carton Labels
Aug 29: IMBRUVICA (ibrutinib) - Risk of Serious and Fatal Cardiac Arrhythmias or Cardiac Failure
Aug 15: Sanitizer: Contains undeclared impurity at elevated levels
Aug 6: Jamp-Atorvastatin 40 mg tablets recalled due to risk of latex contamination
Aug 5: Counterfeit COVID-19 antigen rapid test kits found in Ontario
Jul 28: Apotex recalls Apo-Acyclovir tablets due to a nitrosamine impurity
Jul 27: Philips Respironics recalls several models of CPAP and BiLevel PAP machines and mechanical ventilators
Jul 24: Microbial contamination in magnesium citrate oral solution (Canada-wide) RECALL
Jul 13: Recall of 99.0% Oxygen USP cylinders
Jul 11: Health Canada warns about certain hand sanitizers that may pose health risks (Part 2 – March 31, 2021 to present)
Jul 6: PAXLOVID (nirmatrelvir and ritonavir) - Dosing and Dispensing in Renal Impairment, Risk of Serious Adverse Reactions Due to Drug Interactions, and English-Only Labels
Jun 23: GOJO Canada Inc. recalls a lot of Purell Hand Sanitizing Wipes (Canada-wide) RECALL
Jun 19: Cronobacter sakazakii and Salmonella in powdered infant formula products recalled due to possible (Canada-wide) RECALL
Jun 16: Rocky Mountain Soap Company recalls hand sanitizers due to the potential presence of undeclared methanol (Canada-wide) RECALL
May 13: Various bedbaths and shampoo caps, Conti cleansing wipes and barrier cloths and wet wipes recalled due to possible microbial contamination
May 11: Plasma pens are not authorized in Canada and may pose health risks
May 9: COMIRNATY (COVID-19 Vaccine, mRNA, also referred to as Pfizer-BioNTech COVID-19 Vaccine): New Formulation/Presentation for Use in Individuals 12 Years of Age and Older
May 7: Eye Drops and Compliments Advanced Relief Eye Drops recalled because of a packaging error that may pose health risks
Apr 28: Apotex recalls Apo-Acyclovir tablets due to a nitrosamine impurity
Apr 21: Pfizer recalls Accupril blood pressure tablets due to a nitrosamine impurity
Apr 20: Recall of certain hand sanitizers that may pose health risks
Mar 15: Sodium Acetate Injection, USP - Potential for the Presence of Particulate Matter
Mar 9: 0.9% Sodium Chloride Injection, USP and Lactated Ringer’s Injection, USP - Potential Leak During Pressure Infusion
Mar 3: RUZURGI (amifampridine) - Removal from Canadian Market: Options for Continued Treatment for Lambert-Eaton Myasthenic Syndrome
Mar 3: Ranitidine products recalled because of a nitrosamine impurity
Mar 3: Pfizer recalls Accuretic blood pressure tablets due to a nitrosamine impurity
Mar 1: Pfizer recalls Inderal-LA (propranolol hydrochloride) capsules due to a nitrosamine impurity
Feb 24: Rapid antigen test kits and potential exposure to hazardous substances
Feb 21: Health Canada warns about certain hand sanitizers that may pose health risks
Feb 16: Baxter Corporation’s MiniCap Extended Life Peritoneal Dialysis Transfer Sets: Certain cleaning products, including hand sanitizers and solvents, may damage sets
Feb 3: BEOVU (brolucizumab) – Risk of Intraocular Inflammation, Retinal Vasculitis and/or Retinal Vascular Occlusion
Jan 26: Amitriptyline antidepressant drugs recalled because of a nitrosamine impurity
Jan 17: Important Safety Information on PAXLOVID (nirmatrelvir and ritonavir) Dosing and Dispensing in Renal Impairment, Risk of Serious Adverse Reactions Due to Drug Interactions, and English-Only Labels -Pfizer Canada
Jan 12: XELJANZ/XELJANZ XR (tofacitinib) – Risk of Major Adverse Cardiovascular Events, Malignancy, Thrombosis and Infection
Jan 7: Casirivimab and Imdevimab – High Risk of Treatment Failure Due to Circulation of SARS-CoV-2 Omicron Variant

2021

2020

2019

May 30: Alaris Infusion Sets and Alaris 8100 Pump Module - Risk of Over-Infusion RECALL
May 6: Paclitaxel-Coated Balloons (PCB) and Paclitaxel-Eluting Stents (PES) for the Treatment of Peripheral Arterial Disease (PAD) and the Potential Risk of Long-Term All-Cause Mortality -RECALLL

2018

Sept 26: CDC message regarding Ebola outbreak in DRC
Due to the current Ebola outbreak in eastern Democratic Republic of Congo (DRC) and this year’s earlier outbreak in western DRC, the CDC is reminding healthcare facilities to remain aware of the possibility of imported cases of viral hemorrhagic fevers or other infections in returning travelers. For more information or resources regarding Ebola from the CDC, please click this link.
Sep 23: Possible bacterial contamination in formulated liquid diet (Canada-wide) RECALL

2017

Feb 17: Mycobacterium chimaerainfections in 3T heater-cooler devices (3T HCDs)

2016

Oct 21: Nontuberculous mycobacteria (NTM) infections in heater-cooler devices used in cardiothoracic surgery
Sep 1: Burkholderia cepacia in dimethicone and chlorhexidine gluconate wipes (international) RECALL
Jun 6: National shortage of Benzathine Penicillin G (Bicillin L-A) (Canada-wide)
Mar 24: Microbial contamination of hydrocortisone cream

2015

Jun 20: Possible bacterial contamination of Sodium Bicarbonate Liquid Concentrate (dialysis)

2012

Nov 2: Potential microbiological contamination of Infanrix Hexa Vaccine - RECALL
Oct 15: Pseudomonas aeruginosa in foaming hand soap (triclosan 0.3%) - RECALL
Oct 4: Vi Polysaccharide Typhoid Vaccine Batches with Potentially Lower than Expected Antigen Content (Canada-wide) RECALL
Sep 10: Unlicensed HIV Home Test Kit: CuraHerbDistributor test kit for urine, saliva, blood
Jun 28: Burkholderia cepacia in hand sanitizer (Canada-wide) RECALL

2011

Sep 12: Unlicensed HIV Home Test Kit: Accu-HIV 1 & 2 Saliva Test
May 20: Chronobacter in Docusate Sodium Capsules (Canada-wide) - RECALL
Apr 29: Bacillus cereus and Elizabethkingia meningoseptica in health products - RECALL
Apr 13: Contaminated alcohol prep pads in RUSCH Irrigation Trays
Feb 17: RECALL of lubricating jelly products(Canada-wide)
Jan 11: Urgent RECALL of alcohol swabs(Canada-wide)

2010

Oct. 29: Paecilomyces in hydrocortisone lotion
May 7: Contaminated Rotavirus Vaccine

2009

Dec. 29: Recall for Infection: Carmustine
Sep. 25: Potential medication errors with liquid tamiflu
Jul. 9: Fever following GI endoscopy - investigation - Information not currently available
Mar. 25: Health Canada: Blood lancing devices

2008

Nov. 6: PHAC alert: Re-use of syringes

2007

2006

Nov. 29: Disinfection of glucose meters: alert from Roche
Jun. 23: Perineal Care Washcloths Contaminated with Burkholderia cepacia
Jun. 19: Reprocessing of Reusable Ultrasound Transducers Used for Biopsy
May 19: Bacterial Contamination of Insulin Syringes (Paenibacillus)
Apr. 11: Fungal Contamination of Contact Lens Solution (Fusarium)
Jan 31: Blood Lancing Devices and Bloodborne Diseases
Jan 30: Contamination of Respiratory Gas Humidifiers with Ralstonia

2005

Dec. 28: Risk of Contamination with Surgical Handpieces - further information
Nov. 18: Contamination Risk With Eye Drops
Nov. 18: Contamination Risk With Eye Gel
Nov. 5: Contamination Risk With Artificial Tears
Sep. 20: Contamination Risk With Surgical Handpieces
Mar. 18: Serratia in Contaminated Magnesium Sulfate Solutions
Feb. 4: Pseudomonas in IV Catheter Flushes

2004

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