Field Safety Notices: 7 to 11 June 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 7 to 11 June 2021.
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
ADRIA SRL: TROCART TEK
18 May 2021
Needle biopsy
MHRA reference: 2021/004/014/487/005
Boston Scientific: INGENIO
03 June 2021
Pacemaker
MHRA reference: 2021/006/004/487/003
Cook: Hemospray Endoscopic Hemostat
2021FA0003
Haemostatic agent
Model: HEMO-10-EU and HEMO-7-EU
MHRA reference: 2021/004/006/701/069
Cytocell: E2A (TCF3) Breakapart
08 June 2021
Calibrators
Model: LPH019/LPH019-S
MHRA reference: 2021/005/027/601/503
Cytocell: DiGeorge/VCFS N25 and 22q13.3 Deletion Probe
14 June 2021/VC/2021/005
Reagent
Model: LPU010
MHRA reference: 2021/005/026/601/006
Cytocell:DiGeorge/VCFS TUPLE1,22q13.3 Deletion Probe
19 May 2021/VC/2021/003
Reagent
Model: LPU004
MHRA reference: 2021/005/026/601/005
ELECTRIC MOBILITY EURO:RASCAL
12 May 2021
Wheelchairs, powered
Model: VISION SILVER
MHRA reference: 2021/005/027/601/002
GE Medical Systems: Carestation 750, Carestation 750c
03 June 2021
Machine anaesthetic
Model: 1012-9750-000, 1012-9755-000
MHRA reference: 2021/006/004/487/002
Greiner Bio-One: VACUETTE 9NC Coagulation Tube
22 March 2021
Blood containers
MHRA reference: 2021/003/029/291/003
Intersurgical: Intube Tracheal Tube, Wire Reinforced Cuffed
07 June 2021
Tube endotracheal
Model: 8060070
MHRA reference: 2021/006/007/291/011
Kulzer: PalaXtreme
20 May 2021
Denture Fixative
Model: Liquid & Powder
MHRA reference: 2021/005/012/487/014
Medtronic: DAR airway products
June 2021/FA975 phase II
Circuit breathing
MHRA reference: 2021/004/029/291/001
Medtronic: HeartWare Ventricular Assist System
June 2021/FA981
Ventricular – pump
Model: 1104
MHRA reference: 2021/006/004/487/001
Medtronic: LINQ II Insertable Cardiac Monitor
June 2021/FA979
Implantable heart rate monitor
Model: LNQ22
MHRA reference: 2021/006/003/487/022
Medtronic: Reveal LINQ with TruRhyth Insertable Cardiac Monitoring Systems
June 2021/FA978
Implantable heart rate monitor
Model: LNQ11
MHRA reference: 2021/006/003/487/021
Medtronic: StimLoc Burr Hole Cover
June 2021/FA980
Deep brain stimulators
MHRA reference: 2021/006/003/487/023
Nutricia: Flocare Infinity Pump
17 March 2021
Enteral Nutrition Pump
Model: Infinity II
MHRA reference: 2021/003/018/487/001
Philips Health Systems: CT Fluoroscopy Digital Video Interface (DVI) Package with Ceiling Mounted Portegra2 Extension/Spring Arm by Mavig
27 April 2021
Fluoroscopy system
MHRA reference: 2021/006/003/487/020/07/291/011 021/006/007/291/011
Roche Diagnostics: Elecsys CA 19-9
May 2021
Instrumentation/platform
MHRA reference: 2021/006/010/487/002
Siemens: ARTIS pheno
May 2021
Cardio/angio system
Model: 10849000
MHRA reference: 2021/006/002/601/504