Field Safety Notices: 1 to 5 August 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 August 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
Baxter: TIP CAPS LUER SLIP
29 July 2022
Injection Devices
MHRA reference:
Drive DeVilbiss: Drive
04 August 2022
Mattresses - Active/Passive And Overlays
MHRA reference:
EKF Diagnostic: Biosen Glucose/Lactate hemolysing solution
28 July 2022
IVDs, Haematology
MHRA reference:
GELITA MEDICAL: GELITA-SPON device family
21 July 2022
Haemostatic Agents
MHRA reference:
Genetic Signatures: EasyScreen Pan-Enteric Pathogen Detection Kit
25 July 2022
IVDs, Bacteriology
Model: PE001-HT
MHRA reference:
Kimal: Procedure Packs
20 July 2022
Basic Dressings, Absorbents, Swabs, Procedure Packs
Model:K20253,K2386/P1,K26254,K34027/P1,K38026,K46064/P1,K48787,K53899/P1,K54146/P1/PSP,K56673,K66150/P1,QA-K33721 K46064/P1, K54146/P1/PSP, K64754, K55836/P1
MHRA reference:
Lifescan: OneTouch Reveal Insulin Mentor mobile application
18 July 2022
Software as a Medical Device (SaMD)
MHRA reference:
Matrix Diagnostics: MD 8 Drug Cup
23 June 2022
IVDs, Clinical Chemistry
Model: MD1 198
MHRA reference:
Medtronic: A71200 Vanta LT Clinician Programmer Application
FA1266
Implants, Active, Leads, Neuro
MHRA reference:
Medtronic: Vanta LT Clinician Programmer Application
July 2022
Implantable Neuro Stimulators
Model: A71200
MHRA reference:
Ortho Clinical Diagnostics: VITROS XT 3400 & XT 7600 Systems
22 July 2022
IVDs, Clinical Chemistry
Model: 6844458 & 6844461
MHRA reference:
Stryker: SWANSON Flexspan Finger Joint
July 2022
Joint Prosthesis, Finger
MHRA reference: