Field Safety Notices: 6 to 10 February 2023
List of Field Safety Notices (FSNs) from 6 to 10 February 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
View . FSNs before this date are on the
Abbott: FreeStyle LibreLink App, FreeStyle Libre 3 App / HCP Letter
09 February 2023
MHRA reference:
Abbott: FreeStyle LibreLink App, FreeStyle Libre 3 App / Impacted User Letter
09 February 2023
MHRA reference:
Abbott: FreeStyle LibreLink App, FreeStyle Libre 3 App / Non-Impacted User Letter
10 February 2023
Model: VA170 & VA165Silver
MHRA reference:
Abbott: CardioMEMS Patient and Hospital Electronics System
FA-Q123-HF-1 Electronics System Emissions February 2023
Model: CM1000, CM1100, CM3000
MHRA reference:
Abbott: CardioMEMS PA Sensor and Delivery System
February 2023
Model: CM2000
MHRA reference:
Baxter: Y-Type Blood/Solution Infusion Sets
02 December 2022
MHRA reference:
Baxter: 1.5% Glycine for Irrigation 3000ml, 0.9% Sodium Chloride (NaCl) for Irrigation 3000ml
16 December 2022
MHRA reference:
BD: Infusion Sets 鈥� MicroSet
09 February 2023
MHRA reference:
BD: Alaris GP Plus Guardrails Pump & BD Alaris鈩� neXus GP Pump
30 November 2023
MHRA reference:
GBUK Healthcare: Silicone Pessary
05 December 2022
Model: G64#4, G70#5, G76#6
MHRA reference:
Getinge: Volista STANDOP
06 May 2022
MHRA reference:
Medtronic: Dermalon Monofilament Nylon sutures
Monosof Monofilament Nylon sutures Novafil Monofilament Polybutester Suture Sofsilk Coated Braided Silk Suture Surgilon Braided Nylon suture Surgidac Uncoated Braided Polyester suture Surgipro Monofilament Polypropylene Sutures Surgipro II Monofilament Polypropylene Sutures Ti-Cron Coated Braided Polyester Suture
December 2022
MHRA reference:
Medtronic: Evolut PRO+ Transcatheter Aortic Valve (TAV)
FA1290, December 2022
MHRA reference:
Medtronic: SmartPill SmartBar
February 2023
Model: FGS-0505
MHRA reference:
Medtronic: Medtronic MiniMed Paradigm Infusion Pumps / HCP Letter
January 2023
Model: MMT-512, MMT-712, MMT-515, MMT-715, MMT-522, MMT-722; MMT-554, MMT-754 MMT-508
MHRA reference:
Medtronic: Medtronic MiniMed Paradigm Infusion Pumps / User Letter
January 2023
Model: MMT-512, MMT-712, MMT-515, MMT-715, MMT-522, MMT-722; MMT-554, MMT-754 MMT-508
MHRA reference:
PerkinElmer: DELFIA Inducer
07 February 2023
Model: 3027-0010
MHRA reference:
Siemens Healthineers: ARTIS pheno, ARTIS icono biplane/icono floor
December 2022
MHRA reference:
Siemens Healthineers: ARTIS pheno
January 2023
MHRA reference:
Siemens Healthineers: Atellica DCA HbA1c Dx Reagent
POC 23-006.A.OUS, February 2023
MHRA reference:
Stryker: LIFEPAK庐 CR2 DEFIBRILLATOR
February 2023
MHRA reference:
SynCardia: SynCardia Total Artificial Heart System
03 February 2023
MHRA reference: