Field safety notices - 19 to 23 January 2015
List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 January 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.
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
Navilyst Medical: Xcela™ PICC & BioFlo™ PICC
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