Field Safety Notice: 09 to 13 September 2019
List of field safety notices (FSNs) from medical device manufacturers from 09 to 13 September 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
Aesculap: ENDURO SPECIAL KEY TIB.LOCK.RING Fl /10MM
11 February 2019
Orthopaedic surgical instruments - insertion/extraction tools
NP462R
MHRA reference: 2019/009/011/487/012
Beckman Coulter: Multiple Assay
05 September 2019
IVDs, clinical chemistry
A60298 - Enzymatic Creatinine Reagent (CR-E 2 x 200)
445850 - Triglycerides GPO Blanked Reagent (TG-B 2 x 300)
442785 - Uric Acid Reagent (URIC 2 x 300)
439715 & 476856 Direct Bilirubin Reagent (DBIL 2 x 200)
442745 & 476861 Total Bilirubin Reagent (TBIL 2 x 300)
MHRA reference: 2019/009/006/601/004
GE: Aespire 7100, Aestiva 7900/MRI/7100/100
GEHC Ref: 34101
Anaesthetic machines & monitors
MHRA reference: 2019/009/010/228/018
Gentherm Medical: Blanketrol III
01 August 2019
Heating, patient, electrical pads & blankets 233
MHRA reference: 2019/009/010/228/0182
HemoCue: HemoCue® Glucose 201 DM RT Analyzer
10 September 2019
IVDs, haematology
MHRA reference: 2019/009/010/701/014
LabStyle Innovations: Dario-Blood Glucose Tracker (Android Application)
FA-2019-01; MDSS ref.: IVD19.039
IVDs, self / home testing
1022-02
MHRA reference: 2019/009/011/487/016
Medtronic: Euphora Rapid Exchange Balloon Dilatation Catheter / Solarice Rapid Exchange Balloon Dilatation Catheter
September 2019
Vascular cannula and catheters
MHRA reference: 2019/009/009/291/004
Molnlycke Health Care: Barrier® Sets
29 August 2019
Surgical drapes, gowns, masks
MHRA reference: 2019/008/029/701/018
NxStage Medical: NxStage System One
27 August 2019
Dialysis, haemodialysis
NX1000-1, NX1000-3, NX1000-3-A
MHRA reference: 2019/009/010/701/007
Pajunk: SPROTTE Lumbar
30 August 2019
Injection devices
321151-30C, 331151-31B
MHRA reference: 2019/009/010/601/001
Philips: S7-3t & S8-3t Transesophageal (TEE) Transducers
28 August 2019
Ultrasound, imaging
MHRA reference: 2019/009/009/291/001
Shimadzu: FDR Go
28 June 2019
X ray, mobiles
DR-ID 800
MHRA reference: 2019/009/005/701/020
Teleflex: DispoGrip
06 September 2019
Airway devices
MHRA reference: 2019/009/009/291/002
Terumo: Optia software version 11
27 August 2019
Apheresis
Optia software version 11
MHRA reference: 2018/010/001/401/004