Field Safety Notices: 24 to 28 July 2023
List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 July 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
Abbott: FreeStyle LibreLink App
15 July 2023
Invasive Interstitial-fluid glucose monitoring system
MHRA reference: 5410313
Abbott: FreeStyle LibreLink App
17 July 2023
Invasive Interstitial-fluid glucose monitoring system
MHRA reference:5396820
Abbott: Proclaim, Infinity
July 2023
Spinal Cord-, Deep Brain electr. stimulation sys.
Model: 3660, 3662, 3664, 6660, 6662
MHRA reference: 5388216
B Braun: 2 piece syringes
24 July 2023
Metered-delivery hypodermic syringe
MHRA reference: 5396828
Draeger: HME TwinStar Plus and corresponding sets
July 2023
Heat/moisture exchanger/microbial med. gas filter
MHRA reference: 5394600
ICU Medical: Plum 360 infusion systems
19 July 2023
MHRA reference: 5388210
Philips: Trilogy Evo O2 Trilogy EV300
01 March 2023
MHRA reference: 5394628
Philips: 3D9-3v Transducer
29 June 2023
Ultrasound system, Imaging, General Purpose
Model: 3D9-3v
MHRA reference: 5395815
SCIEX: 4500MD LC-MS/MS System and Citrine LC-MS/MS System
21 July 2023
MHRA reference: 5396894
Siemens Healthineers: ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein
July 2023
Total protein IVD, kit, enzyme spectrophotometry
MHRA reference: 5396889
Siemens Healthineers: ACUSON Redwood ultrasound system
US006/23/S
General-purpose ultrasound imaging system
Model: 11503314
MHRA reference: 5394888
Smith & Nephew: SECURA No-Sting Skin-Prep/Barrier Film
06 July 2023
Synthetic polymer liquid barrier dressing, sterile
MHRA reference: 5396907
TIB Molbiol: LightMix ModularDx Sapovirus
09 March 2023
MHRA reference: 5395898