Field safety notices - 23 to 27 November 2015
List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 November 2015
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.
See more information on what an FSN is and why it’s important.
Latest FSNs
Baxter Healthcare SA: Cytoluer set
November 2015
Infusion & transfusion, administration sets
Model: GMC7405
MHRA reference: 2015/011/020/051/001
Bayer Consumer Care AG: Contour NEXT control solution
FAO 32B
IVDs, self / home testing
Model: blood glucose meters and/or strips
7335, 3329, 7340, 7336, 7341, 7330, 7336, 7342, 7337, 7331, 7342, 3329, 7340, 7336, 7341, 7330, 7336, 7342, 7337, 7331, 7342
MHRA reference: 2015/011/020/292/017
Baylis Medical: ProTrack™ Microcatheter
Catheter guiding
Model: CIC35-145 and CIC38-145
MHRA reference: 2015/011/023/292/006
Cardica: MicroCutter FG-025320 and FG-025321
MDSS ref MDD15 199
Staples and staple guns
MHRA reference: 2015/011/023/292/017
CNSystems Medizintechnik: Task Force monitor
19 November 2015
Monitors, patient
Model: 3040
MHRA reference: 2015/011/025/292/019
GE Medical Systems LLC: MR Surgical Suite Option
FMI 60885
Magnetic resonance, equipment & accessories
Model: M8074SS, M8053SS, M0074SS
MHRA reference: 2015/011/002/292/022
In2Bones SAS: I.B.S compression screw
17 November 2015
Osteosynthesis, bone screws
Model: S25 ST026, S25 ST014, S25 ST022
MHRA reference: 2015/011/020/051/002
Maquet Cardiopulmonary: Quadrox-iD adult/small adult
19 November 2015
Infusion & transfusion, heart lung circuits
Model: HLS; HIT; PLS
MHRA reference: 2015/011/020/292/009
MeCoBo: Sterile X-ray detectable gauze sponge & non-sterile X-ray detectable gauze sponge
17 November 2015
Basic dressings, absorbents, swabs,
MHRA reference: 2015/011/025/601/005
Medline: Sterile procedure trays
24 November 2015
Surgical devices, non-powered MHRA reference: 2015/011/024/292/009
Molnlycke Health Care: Plastipak syringes
26 October 2015
Injection devices
Model: ProcedurePak®
MHRA reference: 2015/010/027/292/012
Olympus Winter & Ibe: Video telescope
20 November 2015
Endoscopes, rigid
Model: ENDOEYE HD II, 10 mm, 0° and 30° WA50040A (0°), WA50042A (30°)
MHRA reference: 2015/011/017/131/002
Philips Healthcare Nederland B.V: Allura Xper/ Allura Clarity/ Allura Centron/ CV20
PH 3226443
X-ray, fluoroscopy systems
Model: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722022, 722023, 722025, 722026, 722400
MHRA reference: 2015/011/024/292/008
Siemens Healthcare Diagnostics: ADVIA Centaur XPT system
November 2015
IVDs, clinical chemistry
Model: SMN10711433
MHRA reference: 2015/011/025/601/007
Terumo: Terumo® Destination® renal guiding sheath
FSCA 1503
Vascular cannula and catheters
MHRA reference: 2015/011/020/292/018
Thermofisher Scientific: Oxoid antimicrobial susceptibility testing disc penicillin G (P1)
18 November 2015
IVDs, bacteriology
Model: CT0152B
MHRA reference: 2015/011/018/601/006