Field Safety Notice - 23 to 27 April 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 April 2018.
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 the latest FSNs
Becton Dickinson: Alaris SMARTSITE ADD-ON BAG ACCESS DEVICE
April 2018
Infusion & transfusion, administration sets
MHRA reference: 2018/004/019/291/003
Becton Dickinson: Model 8100
April 2018
Infusion Systems
MHRA reference: 2018/004/020/478/001
Boston Scientific: INGEVITY™ MRI Extendable/Retractable Fixation leads
April 2018
Implants, active, leads and electrodes
Model: 7740, 7741, 7742
MHRA reference: 2018/004/026/291/011
Cutting Edge: SIP – SIPY – SISA – SISA* – SISAY
28 March 2018
Implants, non active, intraocular
MHRA reference: 2018/003/029/401/006
Edwards Life Sciences: IntraClude™ intra-aortic occlusion device ICF100
April 2018
Vascular cannula and catheters
MHRA reference: 2018/004/009/291/036
Illumina: MiSeqDx Instrument
18 April 2018
IVD, genetic testing
15036706
MHRA reference: 2018/004/020/601/007
Microclean: MicronDevices Sterile Packs
24 April 2018
Injection devices
MHRA reference: 2018/003/022/291/002
Ortho Solutions: RECIPROCATING BLADE 68.0MM X 1.2MM TOOTHED BOTH SIDES
13 March 2018
Surgical power tools
Model: OSA11-912
MHRA reference: 2018/004/022/601/001
Roche Diagnostics: For list of devices see "Accessories"
April 2018
IVDs, clinical chemistry
MHRA reference: 2018/004/018/701/015
Roche Diagnostics: Urisys 1100
April 2018
IVDs, clinical chemistry
Urisys 1100 03617548001
MHRA reference: 2018/004/020/291/005
Siemens: Dimension Gentamicin, Dimension Vista Gentamicin
April 2018
IVDs, clinical chemistry
Model: 10444927, 10445120
MHRA reference: 2018/004/025/601/010
Smiths Medical: Thoracic Catheter 16F Angled Soft, Adult Connector
18 April 2018
Chest drains and accessories
800/002/067, 200/812/160; 200/812/200; 200/812/240;
MHRA reference: 2018/004/012/291/011
Stryker: T2 Ankle Arthrodesis / Femur / Tibia / Recon / Greater Trochanter Nails of the T2 Nailing System / see attachm. PFAA_1774317 affected article no_rev1
23 April 2018
Osteosynthesis, nails intramedullary
MHRA reference: 2018/004/024/291/002
Thermo Fisher Scientific: Oxoid
25 April 2018
IVDs, bacteriology
Model: PB0935A
MHRA reference: 2018/004/024/601/002
Torax Medical: LINX Reflux Management System
2018-04-13 R1
Implants, non active, non vascular stents
MHRA reference: 2018/004/024/291/015
Tornier: Aequalis Humerail Nail Drill Bit Sterile
06 April 2018
Joint prosthesis, knee
MHRA reference: 2018/004/011/478/003
Vygon: Vylife, Kit Vylife
12 February 2018
Lung ventilators
Model: Vylife, Kit Vylife 7506.02, 7506.03, 5582.700, 5582.802, 5582.841, 5582.842/844
MHRA reference: 2018/002/019/291/001