Field Safety Notices: 24 to 28 May 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 24 to 28 May 2021.
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
Bard: Bard Leg Straps
19 May 2021
Urine collection devices and accessories
MHRA reference:
Baxter: Medication Delivery, Nutrition, and Renal Care products
26 May 2021
Infusion & transfusion, administration sets
MHRA reference:
Beckman Coulter: SARS-CoV-2 IgG II Reagent and Calibrator
20 May 2021
IVDs, SARS-CoV-2 antibody immunoassay
MHRA reference:
Gama Healthcare: Clinell Universal Wipes
20 May 2021
Disinfectants for medical devices
Model: CW200
MHRA reference:
Philips: Ingenia Ambition X, Ingenia Ambition S
May 2021/FCO78100524
Magnetic resonance, equipment & accessories
Model: 871356, 871359
MHRA reference:
Phillips: Tempus Pro
07 May 2021/FA-009
Monitors, patient
MHRA reference:
Philips Medical: Allura Xper
May 2021/2020-IGTBST-017
X Ray, fluoroscopy systems
Model: 722026, 722027, 722028, 722029, 722035, 722038, 722058
MHRA reference:
Siemens Healthineers: ADVIA Chemistry XPT
May 2021
IVDs, clinical chemistry
MHRA reference:
Smith and Nephew: JELONET
24 May 2021
Wound management
MHRA reference:
Stryker Trauma: Nail Insertion Sleeve, elastic T2 Tibia SPI
19 May 2021
Osteosynthesis, nails intramedullary
MHRA reference:
Terumo: Extracorporeal blood circuits, Tubing sets
2102鈥�2021-05
Infusion & transfusion, heart lung circuits
Model: CX-BE068X CX-BE093X CX-BE094X CX-CH088X CX-CH094X CX-CH132X CX-CZ095XA CX-CZ095X CX-CZ096X CX-DK098 CX-GE279 CX-UK484 CX-UK575
MHRA reference:
ThermoFisher Scientific: Oxoid MacConkey Agar without Salt
17 May 2021
IVDs, bacteriology
Model: PO0148A
MHRA reference: