Field Safety Notices - 18 July - 22 July 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 18 - 22 July 2016
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
Aptissen: HealaFlow
26 June 2016
Implants, non-active, intraocular Model: A-HEA-060
MHRA reference: 2016/007/005/291/010
Depuy Synthes: Part number 412.812 - Locking Screw Stardrive® Ø 2.4 mm, self-tapping, length 12 mm, Titanium Alloy (TAN) ; Part number 412.812S - Locking Screw Stardrive® Ø 2.4 mm, self-tapping, length 12 mm, Titanium Alloy (TAN), sterile
15 July 2016
Osteosynthesis, bone screws
Model: 412.812 & 412.812S
MHRA reference: 2016/007/019/299/017
DiaSorin: LlAISON® Estradiol II Gen
13 July 2016
IVDs, clinical chemistry
MHRA reference: 2016/007/015/291/001
Gambro Dasco: ARTIS 230V
20 July 2016
Dialysis, haemodialysis
Model: 110635
MHRA reference: 2015/007/023/701/010
Howmedica Osteonics: Triathlon
RA 2016-077
Orthopaedic Surgical instruments
Model: Triathlon Modular Handle
MHRA reference: 2016/007/012/291/015
Macopharma: NPT6280LA / whole blood collection set
20 July 2016
Infusion & transfusion, blood bags
MHRA reference: 2016/006/030/291/004
Ortho Clinical Diagnostics: VITROS Estradiol Reagent Pack
July 2016
IVDs, clinical chemistry
MHRA reference: 2016/007/015/601/005
Philips: MultiDiagnost Eleva, UroDiagnost, MultiDiagnost Eleva with Flat Detector
8 July 2016
X Ray, fluoroscopy systems
Model: 708032 708033 708034 708036 708037 708038
MHRA reference: 2016/007/020/291/012
Shenzhen Mindray Bio-medical:The BeneVision N22 and N19 patient monitors
June 2016
Monitors, patient
MHRA reference: 2016/007/004/701/020
Stryker: Trident constrained liner Impactor tips
RA 2015-181
Orthopaedic surgical instruments - Impacting tools
MHRA reference: 2016/006/030/291/005
Sysmex: FLUOROCELL PLT
19 July 2016
IVDs, Haematology MHRA reference: 2016/006/001/299/005
Trividia: TRUEresult (PQQ), TRUEtrack Test Strips
19 July 2016
IVDs, self / home testing
MHRA reference: 2016/007/020/291/015
Xiros: Infinity-Lock
18 July 2016
Ligaments, tendons and anchors
Model: 102-1088
MHRA reference: 2016/007/018/601/001