医疗器械创新网FDA发布最高级别召回！同类产品都要注意了( 二 ) FDA一级召回

ModelNumbers:
PythonEmbolectomyCatheters:A4E01,A4E02,A4E03,A4E04,A4E05,A4E06,A4E08,A4E09
BardEmbolectomyCatheters:CE0340DR,CE0380DR,CE0440DR,CE0480DRCE0540DR,CE0580DR,CE0680DR
OTWLatisCleaningCatheters:A4GW6
ManufacturingDates:July23,2015toNovember8,2018
DistributionDates:August25,2015toMarch1,2019
DevicesRecalledintheU.S.:19,400
DateInitiatedbyFirm:October24,2019
DeviceUse
ThePythonEmbolectomyCatheters,BardEmbolectomyCatheters,andOTWLatisCleaningCathetersarelatexballooncathetersusedfortemporaryblockage,closingofabloodvessel,orinfusionoffluids.
ReasonforRecall
AppliedMedicalisrecallingtheirPythonEmbolectomyCatheters,BardEmbolectomyCatheters,andOTWLatisCleaningCathetersbecausethereisariskofthecathetertipdetachingduringuse.Ifthetipdetaches,piecesofthecathetercouldbreakoffintothepatient’sbody.
Ifthisoccurs,thereisalsothepotentialforserioushealthconsequencesincludingadditionalsurgicalprocedurestoremovethetip,damagetothebloodvessel,ordeath.
Therehavebeen46complaintsregardingthisdeviceissuesince2015.TheFDAhasreceivedthreemedicaldevicereports(MDRs)andnoreportsofdeathorinjury.
WhoMaybeAffected
HealthcareprovidersusingaffectedPythonEmbolectomy,BardEmbolectomy,andtheOTWLatisCleaningCatheters
Patientsundergoingproceduresusingaffectedcatheters
WhattoDo
OnNovember08,2019,AppliedMedicalsentanUrgent:MedicalDeviceRecallLettertoallaffectedcustomerswiththefollowinginstructions:
Checkyourinventoryfortherecalledproduct.
CompletetheRecallNotificationConfirmationFormtoacknowledgetherecallandindicateifyourfacilityisreturningorhasalreadyusedproductfromthelotlistedabove.
Ifnoproductisbeingreturned,pleaseindicateontheRecallNotificationConfirmationForm.
Ifyouareadistributor,pleasenotifyallthefacilitiesthatreceivedtheaffectedproductofthisrecall.PleasealsocompletePage4oftheRecallNotificationConfirmationForm.
ReturntheRecallNotificationConfirmationFormtoAppliedMedicalbyemailtorecall60810330@appliedmedical.comorbyfaxto949-713-8908.
ReturnaffectedproductandacopyoftheRecallNotificationConfirmationFormtoAppliedMedical(ProductReturnInstructionsareonPage5).
ContactInformation
Forproductreturnquestions,pleasecontactJacleneRios-Simpson,SeniorManager,CustomerRelationsat949-713-8688orjrios@appliedmedical.com.Forregulatoryquestions,pleasecontactLaurenContursi,at949-713-8767orlcontursi@appliedmedical.com.
AdditionalResources:
PythonEmbolectomyRecallDatabaseEntry
BARDEmbolectomyRecallDatabaseEntry
OTWLatisCleaningCathetersRecallDatabaseEntry
HowdoIreportaproblem?
HealthcareprofessionalsandconsumersmayreportadversereactionsorqualityproblemstheyexperiencedusingthesedevicestoMedWatch:TheFDASafetyInformationandAdverseEventReportingProgramusinganonlineform,regularmail,orFAX.
第三届中国医疗器械创新创业大赛
一赛
第三届中国医疗器械创新创业大赛（CMDDEC2020）
一展
2020医疗器械创新与服务展（MISE2020）
三主旨论坛
第十届中国医疗器械高峰论坛（DeviceChina2020）
2020中国国际医疗创新论坛（CMIF2020）

医疗器械创新网FDA发布最高级别召回！同类产品都要注意了( 二 )

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