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Summary of Field Safety Notices - July 2020

Notice type: 3rd Party Publications

Date: 05/08/2020

  

Further Information:
Summary of Field Safety Notices - July 2020

Arjo
Citadel Plus beds
Advice regarding a device modification. HPRA Ref: V44353

Arrow International Inc.
NextStep Retrogade Replacement Hub Set; Cannon II Plus Replacement Hub Set; Single Shot Epidural Anesthesia Kit; TheraCath(R) Epidural Catheter
Advice regarding a device removal. HPRA Ref: V44304

Baxter
EVO IQ Large Volumetric Pump
Advice regarding a software upgrade. HPRA Ref: V44394

Becton, Dickinson
BD PosiFlush™ XS 10mL Syringe
Advice regarding a device removal. HPRA Ref: V43477

Becton, Dickinson and Company
BD SARS-CoV-2 Reagents for the BD Max System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44303

Boston Scientific
Captivator & Captiflex Polypectomy Snares
Advice regarding a device removal. HPRA Ref: V44199

Cardinal Health
Protexis Latex Micro Surigcal Gloves
Advice regarding a device removal. HPRA Ref: V44470

GE Healthcare
Carescape One
Advice regarding a software upgrade. HPRA Ref: V44310

HillRom
Welch Allyn Patient Cables and Lead Sets
Advice regarding a device removal. HPRA Ref: V43168

ICU Medical, Inc.
NanoClave connector
Advice regarding a device removal. HPRA Ref: V44293

ITH icoserve technology for healthcare GmbH
syngo.share view diagnostic
Advice regarding a software upgrade. HPRA Ref: V44461

Jenx / Jiraffe
PU Support Pads
Advice regarding a device removal. HPRA Ref: V44238

Karl Storz SE & Co. KG
Rubber Bulb atomizer
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44308

Life Technologies Corporation, a part of Thermo Fisher Scientific
Applied Biosystems® COVID-19 Interpretive Software
Advice regarding a software upgrade. HPRA Ref: V43982

Maquet Critical Care AB
SoKINOX; Servino
Advice regarding a device modification. HPRA Ref: V44422

MarDx Diagnostic Inc.
Uni-Gold™ S. pneumoniae
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44217

Medtronic Inc.
SynchroMed II Clinician Programmer Application
Advice regarding a software upgrade. HPRA Ref: V44373

Guardian Connect Application - FSN 1 for Patients
Advice regarding the use of the device. HPRA Ref: V44380

Guardian Connect Application - FSN 2 for HCPs
Advice regarding the use of the device. HPRA Ref: V44380

Ossur hf
J-Tong
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44323

Thomas Splint
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44324

Philips Medical Systems
Philips IntelliVue MX700 / MX800 Patient Monitors
Advice regarding a device modification. HPRA Ref: V44337

HeartStart MRx Defibrillator/Monitor
Advice regarding a device modification. HPRA Ref: V44476

Randox Laboratories Ltd.
Randox Soluble Transferrin Receptors Cal & Control
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44396

Roche
Elecsys Troponin T hs. See under "Accessories" - FSN 5
Advice regarding the use of the device. HPRA Ref: V41986

Roche Diagnostics
Elecsys PTH (1-84)
Advice regarding the use of the device. HPRA Ref: V44406

Rocket Medical
FBS Sampling Wand
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44469

Sentinel
Fructosamine
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44255

Siemens Healthcare Diagnostics Limited
CLINITEK Status +Analyzer - FSN 2
Advice regarding a software upgrade. HPRA Ref: V42750

Teleflex Medical
Pleur-evac Chest Drainage Systems
Advice regarding a device removal. HPRA Ref: V44271

ThermoFisher Scientific
Thermo Scientific™ Remel™ Bordetella pertussis agg
Advice regarding a device removal. HPRA Ref: V44432

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