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Summary of Field Safety Notices - February 2024
Notice type:
3rd Party Publications
Date:
01/03/2024
Further Information:
Summary of Field Safety Notices- February 2024
Medtronic Inc.
Duet External Drainage and Monitoring System
Advice regarding a device removal HPRA Ref: CRN00F35V
Abbott Laboratories Diagnostics Division
ARCHITECT STAT Myoglobin Reagent Kit
Advice regarding a device removal HPRA Ref: CRN00F4XD
Acutronic Medical Systems AG
fabian HFO, fabian +nCPAP evolution, and fabian Therapy evolution
Advice regarding changes/updates made to instructions for use HPRA Ref: CRN00F52H
B.Braun Melsungen AG
Original Perfusor® Line
Advice regarding a device removal HPRA Ref: CRN00F3LT
Beckman Coulter Diagnostics Limited
Access Substrate
Advice regarding the use of the device HPRA Ref: CRN00F4K1
Beckman Coulter Diagnostics Limited
DxA 500 Automation System / DxA Aliquoter
Advice regarding the use of the device HPRA Ref: CRN00F55G
BioFire Diagnostics, LLC
BIOFIRE BCID2 Panel
Advice regarding the use of the device HPRA Ref: CRN00F3QC
BioFire Diagnostics, LLC
FilmArray® Gastrointestinal (GI) Panel
Advice regarding the use of the device HPRA Ref: CRN00F3QK
BioFire Diagnostics, LLC
BIOFIRE Pneumoniaplus (PNplus) Panel
Advice regarding the use of the device HPRA Ref: CRN00F3QV
Biorad Medysis PVT LTD
S-Dilator Set
Advice regarding a device removal HPRA Ref: CRN00F119
Boston Scientific Corporation
iSLEEVE™ Expandabel Introducer Set
Advice regarding a device removal HPRA Ref: CRN00F3YD
Boston Scientific Corporation
POLARSHEATH Steerable Sheath
Advice regarding a device removal HPRA Ref: CRN00F405
Caesarea Medical Electronics Limited
BD BodyGuard™ MicroSets
Advice regarding a device removal HPRA Ref: CRN00F4RF
Cook Incorporated
Dilators - Coons Taper; Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Sets; Chiba Biopsy Needles
Advice regarding a device removal HPRA Ref: CRN00F4Z5
Covidien IIc
Surgilon™ Braided Nylon, Sofsilk™ Wax/silicone Coated Braided Silk, Ti-Cron™ Coated Braided Polyester, Monosof™
Monofilament Nylon, Stainless Steel Suture Sutures
Advice regarding a device removal HPRA Ref: CRN00F040
Covidien llc
Kangaroo Enteral Feeding Pump Sets
Kangaroo Enteral Feeding Pump Sets Attachment A
Advice regarding the use of the device HPRA Ref: CRN00DYFP
CU Medical Systems, Inc.
CU-SP1, CU-SP1 AUTO iPAD AEDs
Advice regarding a device removal HPRA Ref: CRN00F2M5
DiaMed GmbH
Anti-k
Advice regarding the use of the device HPRA Ref: CRN00F4RQ
DiaMed GmbH
IH-500
Advice regarding the use of the device HPRA Ref: CRN00F50X
GE Healthcare
Care Plus Incubators / Lullaby incubators
Advice regarding the use of the device HPRA Ref: CRN00F3KR
Globus Medical
ExcelsiusGPS® Cannula A, 9mm x 250mm
Advice regarding a device removal HPRA Ref: CRN00F3MF
Gyrus ACMI, Inc. (Olympus Surgical Technologies America)
Soltive™ SuperPulsed Laser System
Advice regarding the use of the device HPRA Ref: CRN00F3D1
HeartSine Technologies, Ltd. (Stryker Medical)
HeartSine samaritan® PAD 350P/360P/450P/500P
Advice regarding a device removal HPRA Ref: CRN00F4FF
IDENTITES 49
Folding Walking Frame
Advice regarding a device removal HPRA Ref: CRN00F485
In2Bones SAS
Orthopaedic bone screw, non-bioabsorbable, sterile
Advice regarding a device removal HPRA Ref: CRN00F2TK
Medos International SARL
CEREBASE DA Guide Sheath
Advice regarding a device removal HPRA Ref: CRN00F3M8
Medtronic
DLP™ Vessel Cannulae
Advice regarding a device removal HPRA Ref: CRN00F3TV
Medtronic Xomed, Inc.
Medtronic NIM™ Standard Reinforced EMG Endotracheal Tube & NIM CONTACT™ Reinforced EMG Endotracheal Tube
Advice regarding changes/updates made to instructions for use HPRA Ref: V51301
Pemberton Marketing International Limited
TROJAN MAGNUM RIBBED 12CT
Advice regarding a device removal HPRA Ref: CRN00F4PT
Philips Healthcare
Philips Achieva, Ingenia CZ, Intera, SmartPath MR systems with 60cm wide bore
Advice regarding a device modification HPRA Ref: CRN00F1R9
Siemens Healthineers
Atellica IM Cortisol and ADVIA Centaur Cortisol
Advice regarding the use of the device HPRA Ref: V54412
Siemens Medical Solutions USA, Inc. Ultrasound
ACUSON Juniper/Juniper Select ultrasound system
Advice regarding the use of the device HPRA Ref: CRN00F53Y
Siemens Medical Solutions USA, Inc. Ultrasound
ACUSON Redwood ultrasound system
Advice regarding the use of the device HPRA Ref: CRN00F546
Smiths Medical
paraPAC Plus™ ventilators
Advice regarding the use of the device HPRA Ref: CRN00F4KS
SYNOVIS LIFE TECHNOLOGIES INC.
Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, Vascular Probe Intravascular Probe, Ma Recette Mitonnee Leg MP 6
Advice regarding the use of the device HPRA Ref: CRN00F59Q
Synthes GmbH
Trochanteric Fixation Nail - Advanced; 2.7mm VA LCP Clavicle Plates System; OPAL Intervertebral Cage
Advice regarding a device removal HPRA Ref: CRN00F2W7
Thoratec Corporation
HeartMate II & HeartMate 3 LVAS Kits & Outflow Grafts
Advice regarding the use of the device HPRA Ref: CRN00F4JW
VOCO GmbH
Ionolux Advice regarding a device removal
Vygon POLYPERF SAFE®
Advice regarding a device removal HPRA Ref: CRN00F3SM
Werfen
ACL TOP FAMILY 50 SERIES
Advice regarding a software upgrade HPRA Ref: CRN00DQ7Z
William A. Cook Australia Pty Ltd
MINC+ Benchtop Incubator
Advice regarding a device modification HPRA Ref: CRN00DZKL
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Date Printed: 30/04/2024