Field Safety Notice: 12 to 16 August 2019
List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 August 2019.
Overview
If you receive a field safety notice (FSN) from a manufacturer you must always act on it.
MHRA publishes the following for information only.
If you have a question about a particular FSN contact the manufacturer.
Latest FSNs
View the latest
Arjo: Concerto / Basic Shower Trolley
12 August 2019
Trolleys and chairs
BAB1000-01, BAB1000CON6102, BAB1007-01, BAB1101-01,
MHRA reference:
Biomatrica: LBgard Blood Collection Tube
08 August 2019
Storage & collection devices
CE-71001-002
MHRA reference:
BioPro
26 June 2019
Central sterilisation services materials
MHRA reference:
Breas Medical: NIPPY 22mm Breathing circuits
07 August 2019
Breathing system components
0792/Sp1, 0793/SP1, 0794/SP7, 0791/SP7v1, 0794/SP10, 0805/
MHRA reference:
Fresenius: NaCl 0,9% Fresenius CFX DUO 3000ml
17 June 2019
Infusion & transfusion, administration sets
F1335161 / F1339161
MHRA reference:
Gambro - Baxter: Prismaflex System, Prismaflex 4.11, Prismaflex 5.00 Row, Prismaflex 6.10
Row, Prismaflex 7.XX Row
August 2019
Dialysis, haemodialysis
Machine Haemodialysis: 114870, 113874, 107493, 114489, 113082
MHRA reference:
Gentherm Medical: Norm-O-Temp 111W
14 August 2019
Heating, patient, electrical pads & blankets
Norm-O-Temp 111W
MHRA reference:
Medineering: Surgical Base System
09 August 2019
Operating table
Surgical Base System SBS 1.3
MHRA reference:
Medtronic: Micra Transcatheter Leadless Pacemaker system
August 2019
Implants, active, intracardiac (leadless)
MC1VR01
MHRA reference:
Nihon Kohden: CSM-1500 and CSM-1700
August 2019
Monitors, Patient
Model: CSM-1500 and CSM-1700
MHRA reference:
Radiometer: AQURE system
FAN 915-398
IVDs, extra laboratory testing
933-599
MHRA reference:
Siemens: Atellica CH 930 Analyzer
July 2019
IVDs, clinical chemistry
Atellica CH 930 Analyzer
MHRA reference:
Thermo Fisher: Oxoid
08 August 2019
IVDs, bacteriology
MA0121D/F
MHRA reference:
Xenios: Notfall CP Set, short duration, mit hilite 2800 and Notfall CP Set, short duration, mit hilite 2800 unsteril
26 June 2019
Infusion and transfusion, heart lung circuits
MHRA reference:
Updates to this page
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Added FSN for Xenios: Notfall CP Set, short duration, mit hilite 2800 and Notfall CP Set, short duration, mit hilite 2800 unsteril
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List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 August 2019.
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First published.