Field safety notices - 9 to 13 March 2015
List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 March 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.
Latest FSNs
View the latest FSNs
Boston Scientific: Biliary Drainage Catheter and Biliary Drainage
9 March 2015
Wound drains
Model: Expel™ Drainage Catheter with Twist-Loc™ Hub
MHRA reference: 2015/003/004/131/004
Candela: GentleLase Pro
19 November 2013
Therapy, lasers
Model: 9914-00-9015
MHRA reference: 2015/003/009/121/011
Chien Ti Enterprise Co.: Leo / Comet / Orion
2 March 2015
Scooters, powered
Model: Leo / Comet / Orion
MHRA reference: 2015/003/003/081/024
Fresenius Medical Care: FX CorDiax 40, 50, … 120 and FX CorDiax HDF600
9 March 2015
Dialysis, haemodialysis
Model: F00001588, F00001589, F00001590, F00001591, F00001592, F00002384, F00005649, F00005650, F00005651, F00005652, F00001593, F00001594, F00001595
MHRA reference: 2015/003/010/081/017
Galt Medical Corporation: 4.5FG SELDINGER TECHNIQUE 7CM SHEATH
10 March 2015
Vascular cannula and catheters
Model: G1146-457
MHRA reference: 2015/003/011/601/005
Medex: FlowSENS
2 March 2015
Media injectors
Model: FlowSENS
MHRA reference: 2015/002/009/081/022
Medicina: IVL60 (INS) 60ml Luer Lock IV Syringe for Insulin
22 October 2014
Device description: insulin injection devices
MHRA reference: 2014/010/016/601/005
Medicina: Medicina Blue Gastrostomy Clip
2 March 2015
Feeding systems and tubes
Model: GC01
MHRA reference: 2015/002/017/601/014
Medicina: Medicina Purple Syringe Pump
2 March 2015
Feeding systems and tubes
Model: P700
MHRA reference: 2015/002/017/601/015
Medicina: Medicina Oral Tip Bulk (non-sterile)
2 March 2015
Feeding systems and tubes
Model: OTCB500
MHRA reference: 2015/002/017/601/016
Medicina: Medicina ACE Stopper Dressing
2 March 2015
Wound management
Model: SD02
MHRA reference: 2015/002/017/601/019
Ortho Clinical Diagnostics
February 2015
IVDs, blood transfusion
Model: ORTHO VISION analyser for ORTHO BioVue Cassettes
MHRA reference: 2015/002/013/601/001
Ossur: LP Rotate
2 March 2015
Prostheses
Model: LP Rotate; LRP062,LRF062,LRPU62,LRFU62
MHRA reference: 2015/003/005/081/028
Philips Healthcare: IntelliVue Clinical Information Portfolio (ICIP); 865047, 865209, 866072, 866148
29 October 2014
Monitors, patient
Model: IntelliVue Clinical Information Portfolio (ICIP); 865047, 865209, 866072, 866148 /
MHRA reference: 2014/012/001/081/003
Rocket Medical Factories 2- 3-4
25 February 2015
Chest drains and accessories
Model: R54565
MHRA reference: 2015/003/006/601/006
Siemens Medical Solutions Diagnostics: IMMULITE 2000, IMMULITE 2000XPi
March 2015
IVDs, clinical chemistry
Model: IMMULITE® 2000, IMMULITE® 2000 XPi
MHRA reference: 2015/003/009/601/001
Siemens Medical Solutions Diagnostics: ADVIA Centaur XPT
March 2015
IVDs, clinical chemistry
Model: ADVIA Centaur XPT
MHRA reference: 2015/003/009/601/012
Stryker Instruments: System 6 Aseptic Housing Battery
10 February 2015
Surgical power tools
Model: System 6 Aseptic Housing Battery
MHRA reference: 2015/001/020/081/002