Field safety notices - 19 to 23 January 2015

List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 January 2015.


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.

PDF copies of FSNs

You can see copies of this week’s field safety notices in our filecamp folder.

Latest FSNs

Zimmer: Trilogy® Fiber Metal Acetabular Shell – Size 54

16 January 2015

Device description: Joint prosthesis

MHRA reference: 2015/001/015/081/024

31 December 2014

Device description: Vascular cannula and catheters

Model: Xcela™ PICC & BioFlo™ PICC

MHRA reference: 2015/001/019/081/002

Corin: Taperfit; Metafix

15 January 2015

Device description: Joint prosthesis, hip

Model: 588.4500, 588.3801, 579.2003, 588.4502

MHRA reference: 2015/001/016/601/002

Siemens Medical Solutions: ACUSON SC2000 ultrasound system

22 September 2014

Device description: Ultrasound unit

Model: 10433816

MHRA reference: 2015/001/016/601/002

Smiths Medical International: Single Limb Circuit for Pneupac® Ventilators, with PEEP Valve

19 January 2015

Device description: Breathing system components

Model: Single Limb Circuit for Pneupac® Ventilators, with PEEP Valve

MHRA reference: 2015/001/015/081/024

Siemens Healthcare Diagnostics Products: N Latex IgM

1 December 2014

Device description: Assay kit immunoassay

Model: SMN 10446035

MHRA reference: 2014/012/023/081/011

Trinity Biotech: Lab21

Device description: IVDs, bacteriology reagent

Model: Stop Solution (916401) used in Bio-Rad Syphilis TA (72519/72519SP)

MHRA reference: 2014/012/008/601/003

Roche Diagnostics: cobas b 121

2 December 2014

Device description: IVDs, extra laboratory testing

MHRA reference: 2014/009/004/121/010

Cellnovo: Cellnovo insulin pump system

14 January 2015

Device description: Infusion systems

MHRA reference: 2014/011/027/081/006

Christoph Miethke: ProGAV 2

Device description: Lung ventilators

MHRA reference: 2015/001/019/081/019

Dentisan, Quadralene: Biocleanse Ultra wipes and wipe refills

Device description: Disinfectants for medical devices

MHRA reference: 2015/001/013/081/011

Zimmer: Biolox Delta Head, Durasul

13 January 2015

Device description: IVDs, clinical chemistry

MHRA reference: 2015/001/016/601/013

Becton Dickinson Biosciences: BD CD138 PE

12 January 2015

Device description: IVDs, clinical chemistry

MHRA reference: 2015/001/016/601/013

Zimmer: Persona-Constrained Tibial Artic. Surf. Prov. Shim

20 January 2015

Device description: Surgical instruments, implant trial prostheses

MHRA reference: 2015/001/020/081/008

Stryker Instruments-Kalamazoo: Neptune waste management system

22 January 2015

Device description: Surgical devices, non-powered

MHRA reference: 2014/012/008/701/001

Biocoat: HBA Sperm Hyaluronan Binding Assay

18 December 2015

Device description: Laboratory equipment associated with IVF, cells, tissues

MHRA reference: 2014/012/004/081/008

Masimo Corporation: Masimo SET uSpO2 Pulse Oximetry Cable

23 December 2014

Device description: Monitors, patient

Model: Oximeter

MHRA reference: 2015/001/002/701/009

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