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 FSNs
Arjo: Concerto / Basic Shower Trolley
12 August 2019
Trolleys and chairs
BAB1000-01, BAB1000CON6102, BAB1007-01, BAB1101-01,
MHRA reference: 2019/008/009/601/007
Biomatrica: LBgard Blood Collection Tube
08 August 2019
Storage & collection devices
CE-71001-002
MHRA reference: 2019/008/009/701/007
BioPro
26 June 2019
Central sterilisation services materials
MHRA reference: 2019/006/028/701/010
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: 2019/008/009/487/010
Fresenius: NaCl 0,9% Fresenius CFX DUO 3000ml
17 June 2019
Infusion & transfusion, administration sets
F1335161 / F1339161
MHRA reference: 2019/006/014/601/009
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: 2019/008/013/487/036
Gentherm Medical: Norm-O-Temp 111W
14 August 2019
Heating, patient, electrical pads & blankets
Norm-O-Temp 111W
MHRA reference: 2019/008/006/487/010
Medineering: Surgical Base System
09 August 2019
Operating table
Surgical Base System SBS 1.3
MHRA reference: 2019/008/009/701/028
Medtronic: Micra Transcatheter Leadless Pacemaker system
August 2019
Implants, active, intracardiac (leadless)
MC1VR01
MHRA reference: 2019/008/013/487/035
Nihon Kohden: CSM-1500 and CSM-1700
August 2019
Monitors, Patient
Model: CSM-1500 and CSM-1700
MHRA reference: 2019/008/015/487/007
Radiometer: AQURE system
FAN 915-398
IVDs, extra laboratory testing
933-599
MHRA reference: 2019/007/019/701/004
Siemens: Atellica CH 930 Analyzer
July 2019
IVDs, clinical chemistry
Atellica CH 930 Analyzer
MHRA reference: 2019/008/012/601/006
Thermo Fisher: Oxoid
08 August 2019
IVDs, bacteriology
MA0121D/F
MHRA reference: 2019/008/008/601/004
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: 2019/007/015/701/007
Last updated 25 September 2020 + show all updates
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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.