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
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View . FSNs before this date are on the .
Abbott: Alinity s HIV Ag/Ab Combo Reagent Kit
28 April 2022
IVDs, viral microbiology
MHRA reference:
BD: Connecta with extension tube
12 May 2022
Infusion & transfusion, connectors
MHRA reference:
BD: Refer to FSN
BDB-22-4384a
IVDs, clinical chemistry
MHRA reference:
BD: Refer to FSN
BDB-22-4384b
IVDs, clinical chemistry
MHRA reference:
Bio-Rad: Anti-Lua (LU1)
18 May 2022
IVDs, blood transfusion
MHRA reference:
Blink Medical: Sternal Retractor
03 May 2022
Surgical devices, non-powered
MHRA reference:
Cook Medical: Hilal, Nester, and Tornado Embolization Microcoils
2022FA0001
Embolisation coils
MHRA reference:
Drager: SafeStar 55
May 2022
Lung ventilators
Model: MP01790
MHRA reference:
GE Healthcare: MUSE Cardiology Information System
30102-2
Software as a medical device (SaMD)
MHRA reference:
GE Healthcare: Carescape R860, Engstr枚m Carestation, Engstr枚m Pro
34126
Lung ventilators
MHRA reference:
Haemonetics: Functional Fibrinogen Kit
02 May 2022
IVDs, clinical chemistry
Model: Kit4
MHRA reference:
M.I.Tech: HANAROSTENT Esophagus TTS (NCN)
April 2022
Implants, non active, nonvascular stents
MHRA reference:
Macopharma: LQT614B and NQT614B
25 April 2022
Infusion & transfusion, autologous
MHRA reference:
Medtronic: HeartWare Ventricular Assist System
April 2022
Implantable ventricular assist devices
Model: MCS1705PU, 1104
MHRA reference:
Medtronic: Argyle Fistula Cannulas with Anti-Reflux Valve 1530VSVS
FA1251
Dialysis, haemodialysis
MHRA reference:
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:
Medtronic: HeartWare Ventricular Assist System, HeartWare Battery
FA1257
Implantable ventricular assist devices
Model: 1650DE
MHRA reference:
Medtronic: EEA Auto Suture Circular Stapler with DST Series Technology 25mm
May 2022
Staples and staple guns
Model: EEA25, EEA2535, EEAXL25, EEAXL2535
MHRA reference:
MicroVention Terumo: CASPER Carotid Artery Stent CPR-0830-143RX
25 April 2022
Implants, non active, carotid artery stents
MHRA reference:
Roche: Accu-Chek Insight Adapter & Tubing
23 May 2022
Infusion & transfusion, administration sets
MHRA reference:
Schwarzer Cardiotek: EP-TRACER
22 April 2022
Monitors, patient
Model: EP-TRACER 38, EP-TRACER 102
MHRA reference:
Trinity Biotech: Premier Resolution Analyzer
29 April 2022
IVDs, haematology
MHRA reference: