Field Safety Notices: 16 to 20 May 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 May 2022.
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.
Abbott: Alinity s HIV Ag/Ab Combo Reagent Kit
28 April 2022
IVDs, viral microbiology
MHRA reference: 2022/005/002/701/018
BD: Connecta with extension tube
12 May 2022
Infusion & transfusion, connectors
MHRA reference: 2022/005/013/613/005
BD: Refer to FSN
BDB-22-4384a
IVDs, clinical chemistry
MHRA reference: 2022/005/017/599/002
BD: Refer to FSN
BDB-22-4384b
IVDs, clinical chemistry
MHRA reference: 2022/005/017/599/003
Bio-Rad: Anti-Lua (LU1)
18 May 2022
IVDs, blood transfusion
MHRA reference: 2022/005/017/613/005
Blink Medical: Sternal Retractor
03 May 2022
Surgical devices, non-powered
MHRA reference: 2022/005/013/595/002
Cook Medical: Hilal, Nester, and Tornado Embolization Microcoils
2022FA0001
Embolisation coils
MHRA reference: 2022/005/012/613/008
Drager: SafeStar 55
May 2022
Lung ventilators
Model: MP01790
MHRA reference: 2022/005/003/701/017
GE Healthcare: MUSE Cardiology Information System
30102-2
Software as a medical device (SaMD)
MHRA reference: 2022/005/013/613/004
GE Healthcare: Carescape R860, Engström Carestation, Engström Pro
34126
Lung ventilators
MHRA reference: 2022/005/018/613/005
Haemonetics: Functional Fibrinogen Kit
02 May 2022
IVDs, clinical chemistry
Model: Kit4
MHRA reference: 2022/005/016/599/002
M.I.Tech: HANAROSTENT Esophagus TTS (NCN)
April 2022
Implants, non active, nonvascular stents
MHRA reference: 2022/005/012/593/003
Macopharma: LQT614B and NQT614B
25 April 2022
Infusion & transfusion, autologous
MHRA reference: 2022/005/012/593/001
Medtronic: HeartWare Ventricular Assist System
April 2022
Implantable ventricular assist devices
Model: MCS1705PU, 1104
MHRA reference: 2022/005/012/611/003
Medtronic: Argyle Fistula Cannulas with Anti-Reflux Valve 1530VSVS
FA1251
Dialysis, haemodialysis
MHRA reference: 2022/005/014/590/001
Medtronic: EMG TUBE REINFORCED 6MM / PRO PIN; EMG TUBE REINFORCED 7MM / PRO PIN (1/EA); EMG TUBE REINFORCED 8MM / PRO PIN (1/EA)
ENDOTRACHEAL TUBE 6MM EMG CONTACT (1/EA); ENDOTRACHEAL TUBE 7MM EMG CONTACT (1/EA); ENDOTRACHEAL TUBE 8MM EMG CONTACT (1/EA)
FA1255
Airway devices
Model: 8229306, 8229307, 8229308 (GMDN 46569), 8229506, 8229507, 8229508 (GMDN 46967)
MHRA reference: 2022/005/017/613/002
Medtronic: HeartWare Ventricular Assist System, HeartWare Battery
FA1257
Implantable ventricular assist devices
Model: 1650DE
MHRA reference: 2022/005/014/590/002
Medtronic: EEA Auto Suture Circular Stapler with DST Series Technology 25mm
May 2022
Staples and staple guns
Model: EEA25, EEA2535, EEAXL25, EEAXL2535
MHRA reference: 2022/005/016/611/001
MicroVention Terumo: CASPER Carotid Artery Stent CPR-0830-143RX
25 April 2022
Implants, non active, carotid artery stents
MHRA reference: 2022/004/025/601/500
Roche: Accu-Chek Insight Adapter & Tubing
23 May 2022
Infusion & transfusion, administration sets
MHRA reference: 2022/005/018/611/001
Schwarzer Cardiotek: EP-TRACER
22 April 2022
Monitors, patient
Model: EP-TRACER 38, EP-TRACER 102
MHRA reference: 2022/005/013/611/002
Trinity Biotech: Premier Resolution Analyzer
29 April 2022
IVDs, haematology
MHRA reference: 2022/005/013/611/003