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

View the 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

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