Field Safety Notices: 21 to 25 August 2023
List of Field Safety Notices from 21 to 25 August 2023
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Philips: Xper Flex Cardio Device
23 August 2023 Physiomonitoring System and Philips Hemo System Model: FC2010 & FC2020 MHRA reference: 27355833 Distributor Letter - 2023/009/004/601/016 MHRA reference: 27355833 FSN
Abbott: Apical Coring Knife
August 2023 Heart Ventricle Prosthesis Model: 106524INT MHRA reference: 24572577
B Braun Medical: Infusomat Space
August 2023 Bedside infusion pump, single-channel MHRA reference: 23831841
B Braun Medical: Spaceplus Infusomat
August 2023 Bedside infusion pump, single-channel MHRA reference: 23363353
DePuy Synthes: BioKnotless Anchor
April 2023 Model: 212724, 212725, 212726, 212722, 212723 MHRA reference: 22192340
Drager: Babyroo TN300
August 2023 Infant Warmer MHRA reference: 20503932
Getinge: MEERA operating table with autodrive
August 2023 Universal operating table, electrohydraulic Model: 7200.01B2, 7200.01F2, 7100.01B2 MHRA reference: 13515945
Invivoscribe: LymphoTrack Dx IGH - MiSeq
August 2023 Model: 91210109 - LymphoTrack Dx IGH FR3 Assay - Kit A - MiSeq, 91210119 - LymphoTrack Dx IGH FR3 Assay - Panel - MiSeq, 91210129 - LymphoTrack Dx IGH FR1/2/3 Assay - Kit A - MiSeq, 91210139 - LymphoTrack Dx IGH FR1/2/3 Assay - Panel - MiSeq MHRA reference: 25619485
Medline International France: Hudson RCI AQUAPAK Humidifier Adaptors
August 2023 MHRA reference: 22072866
Medtronic: Palindrome Chronic Catheter Kit Symmetrical Tip 14
August 2023 Double-lumen haemodialysis catheter, implantable Model: 8888145015 MHRA reference: 23404435
Ossur: Icelock Ratchets
April 2023 Extern lower-limb prosthesis suspensory component Model: L-125000; L-621200; L-621000; L-621100; L-692020 MHRA reference: 20293768
Revvity: Vanadis Extract Reaction Plates
August 2023 Model: 4306-0010 MHRA reference: 20341036
Smiths Medical: Medfusion syringe infusion pumps
August 2023 Model: 3500, 4000 MHRA reference: 21983249
Wom: Aquilex Fluid Control System
July 2023 Hysteroscopic irrigation/insufflation system Model: AQL-100PBS and AQL-100P MHRA reference: 8914228
Xiamen Compower Medical: Compower
CP 2023-1_ Compower PVC Manual Resuscitator Model: YA-3#+M5 MHRA reference: 20540311