My HPRA: Register

Summary of Field Safety Notices - August 2022

Notice type: 3rd Party Publications

Date: 07/09/2022

  

Further Information:
Datascope Corp. / Getinge
Insertion Kit for use with SENSATION PLUS 8Fr. 50cc IAB, SENSATION PLUS 8Fr. 50cc IAB Catheter, and MEGA 8Fr. 50cc IAB Catheter
Advice regarding a device removal. HPRA Ref: V52265


Alere San Diego, Inc.
Cholestech LDX Test Cassettes
Advice regarding changes/updates made to instructions for use. HPRA Ref: V52093


Associates of Cape Cod, Inc.
Fungitell STAT
Advice regarding a device removal. HPRA Ref: V52335


CB Healthcare Consulting GmbH
Self-Aspirating Syringe Dual Action
Advice regarding a device removal. HPRA Ref: V52325


CooperSurgical
Humidifier Bottle and SHumidifier Bottle and Syringe filter kit for BT37 yringe filter kit for BT37
Advice regarding a device removal. HPRA Ref: V52285


CooperVision
All in one light(60ml) multipurpose contact lens care solution
Advice regarding a device removal. HPRA Ref: V52219


Fannin Ltd (LIP)
GC Sensitivity Test Medium
Advice regarding a device removal. HPRA Ref: V52396


GE Healthcare
Avance CS2, Avance CS2 Pro, Aisys CS2
Advice regarding the use of the device. HPRA Ref: V52437


GE Medical Systems Information Technologies, Inc.
Carescape Central Station
Advice regarding the use of the device. HPRA Ref: V52214


ICU Medical, Inc.
IV Connectors and Sets & Intravascular Admin Sets
Advice regarding a device removal. HPRA Ref: V52271


Illumina, Inc.
NextSeq 550Dx Instrument / MiSeq Dx Instrument
Advice regarding a software upgrade. HPRA Ref: V51267


Intersurgical Ltd
SOLUS SINGLE USE LARYNGEAL MASK AIRWAY SIZE 3
Advice regarding a device removal. HPRA Ref: V52445


Intuitive Surgical Inc.
da Vinci S/Si and X/Xi EndoWrist Clip Applier Instruments
Advice regarding a software upgrade. HPRA Ref: V52247


LaVita GmbH
Lloyds Pharmacy Early Pregnancy Test (single)
Advice regarding a device removal. HPRA Ref: V52155


Leica Microsystems (Schweiz) AG
ARveo 8, ARveo, M530 OHX, PROvido;
Advice regarding a device modification. HPRA Ref: V52427


Limacorporate S.p.A.
Helix Drill Dia. 3.5mm
Advice regarding a device removal. HPRA Ref: V52511


Löwenstein Medical Technology
Luisa Ventilator LM150TD
Advice regarding a software upgrade. HPRA Ref: V52291


Maquet Cardiopulmonary GmbH
HLS Set Advanced 5.0, HLS Set Advanced 7.0
Advice regarding a device removal. HPRA Ref: V52053


Medtronic
Cobalt / Crome ICD; CareLink SmartSync Device Manager
Advice regarding a software upgrade. HPRA Ref: V51792


Medtronic Inc.
Vanta LT Clinician Programmer Application
Advice regarding the use of the device. HPRA Ref: V52161


Nutricia Medical Devices BV
Nutricia Flocare Infinity II – enteral feeding pump. Cover Letter
Nutricia Flocare Infinity II – enteral feeding pump. FSN
Advice regarding changes/updates made to instructions for use. HPRA Ref: V52274


Philips Respironics
Amara View Minimal Contact Full-Face Mask (Full Face Mask) DreamWear Full Face Mask (Full Face Mask) DreamWisp Nasal Mask with Over the Nose Cushion (Nasal Mask) Wisp Nasal Mask (Nasal Mask) Wisp Youth Nasal Mask (Nasal Mask) Therapy Mask 3100 NC/SP (Nasal Mask) FSN 1
Amara View Minimal Contact Full-Face Mask (Full Face Mask) DreamWear Full Face Mask (Full Face Mask) DreamWisp Nasal Mask with Over the Nose Cushion (Nasal Mask) Wisp Nasal Mask (Nasal Mask) Wisp Youth Nasal Mask (Nasal Mask) Therapy Mask 3100 NC/SP (Nasal Mask) FSN 2
Advice regarding changes/updates made to instructions for use. HPRA Ref: V52317


Philips Respironics
BiPAP A30, BiPAP A40 and OmniLab Advanced+. FSN 1
BiPAP A30, BiPAP A40 and OmniLab Advanced+. FSN 2
Advice regarding a device removal. HPRA Ref: V52426


Randox Laboratories Limited
Randox Serology I Positive Control
Advice regarding changes/updates made to instructions for use. HPRA Ref: V52209


Regen Lab
RegenKit-BCT Family
Advice regarding a device removal. HPRA Ref: V52326


Siemens Healthcare Diagnostics Inc
Dimension® Magnesium (MG) Flex® reagent cartridge
Advice regarding a device removal. HPRA Ref: V50328


Siemens Healthcare Diagnostics Products GmbH
N Antiserum to Human IgG
Advice regarding the use of the device. HPRA Ref: V52307


Siemens Healthcare GmbH
Artis Q, Artis Q.zen, ARTIS pheno, and ARTIS icono X-ray Systems
Advice regarding a device modification. HPRA Ref: V52315


Smiths Medical
Level 1® H-2 Pressure Chambers
Advice regarding a device modification. HPRA Ref: V51980

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