Field Safety Notices - 13 February - 17 February 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 13 February - 17 February 2017
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
Abbott Laboratories: CELL-DYN Ruby
13 February 2017
IVDs, haematology
MHRA reference: 2017/002/015/701/002
Abbott Vascular: StarClose SE Vascular Closure System
10 February 2017
Vascular closure device
Model: StarClose SE Vascular Closure System; 14679 (US), 14679-01 (China), 14679-02 (Europe, Middle East, Africa, Latin America, Canada and Asia Pacific)
MHRA reference: 2017/002/008/291/008
Animas Corporation: Animas Insulin Pumps
19 September 2016
Infusion systems
Model: Animas Vibe Insulin Pumps
MHRA reference: 2017/001/030/601/017
B. Braun: Dialog+
19 November 2015
Dialysis, haemodialysis
Model: Dialog+
MHRA reference: 2015/011/020/291/001
Bio-Rad: ID-DiaCell's
10 February 2017
IVD, genetic testing
Model: ID-DiaCell's
MHRA reference: 2017/002/013/291/011
BioCardia: Fluid/device delivery cardiac catheter
15 February 2017
Implants, non-active, cardiovascular heart valves
Model: 00953L
MHRA reference: 2017/002/015/601/004
CareFusion: Alaris Plus Syringe Pump
1 February 2017
Infusion systems
Model: 8005TIG01
MHRA reference: 2017/002/016/291/014
Chalice Medical: ParaTherm
10 February 2017
Blood/Fluid warming systems
Model: Paratherm
MHRA reference: 2017/002/014/601/009
Coris BioConcept: RESIST-3 O.K.N. K-set
13 February 2017
IVDs, bacteriology
Model: RESIST-3 O.K.N. K-set Cassette
MHRA reference: 2017/002/014/299/017
Depuy Synthes: Distractor; Removal Tool; Retractor; Inserter
15 February
Orthopaedic surgical instruments - Insertion/extraction tools Model: Distractor; Removal Tool; Retractor; Inserter 396.396; 03.812.005; 03.632.087; 03.820.129 MHRA reference: 2017/002/014/299/028
Ella-CS: SX-ELLA Stent Danis Procedure Pack (Basic)
14 February 2017
Implants, non-active, non-vascular stents
MHRA reference: 2017/002/015/291/004
Greatbatch Medical: MOBICATH™ Bi-Directional Guiding Sheath
2183787-02/07/2017-001-R
Vascular cannula and catheters
MHRA reference: 2017/002/015/701/012
Gyrus ACMI: Gyrus ACMI Diego Elite Tubeset
January 2017
Surgical equipment, miscellaneous Model: Gyrus ACMI Diego Elite Tubeset; TS100S, TS101DC
MHRA reference: 2017/002/010/601/007
Hoya Corporation: PENTAX Ultrasound-Video Bronchoscope
FSCA-PMJ-16-03-1
Endoscopes, flexible
Model: EB-1970UK PENTAX Ultrasound-Video Bronchoscope
MHRA reference: 2017/002/001/291/014
LivaNova: FlexTherm Device
6 February 2017
Blood/fluid warming systems
Model: 16-70-00
MHRA reference: 2017/002/016/299/006
Medtronic MiniMed: MiniMed 640G Insulin Pump
February 2017
Ambulatory insulin infusion pump
Model: MMT-1711, MMT-1712
MHRA reference: 2017/002/001/291/017
MicroPort Orthopedics: BIOLOX FORTE 36mm Alumina ceramic head
8 February 2017
Joint prosthesis, hip
Model: 26000010, 26000011, 26000012
MHRA reference: [2017/002/010/291/013]https://mhra-gov.filecamp.com/s/IKcSGBU4tuuz7Ogw/d)
Pennine Healthcare: Covidien Devon Light Glove
3 February 2017
Lamps & lights
MHRA reference: 2017/002/013/701/019
Roche: cobas p 612 pre-analytical system
15 December 2016
IVDs, clinical chemistry
Model: 07563116001
MHRA reference: 2016/012/020/701/016
Spacelabs Healthcare: Arkon Anesthesia Delivery System
15 February 2017
Anaesthetic machines & monitors
Model: 99999
MHRA reference: 2017/002/015/291/006
Stealth Products: Stealth
8 February 2017
Wheelchairs, accessories
Model: TWB480-17FDM, TWB486-17FDM, TWB480-1FDM, TWB486-1FDM
MHRA reference: [2017/002/009/601/001]https://mhra-gov.filecamp.com/s/OHYGfJ37lMRcleCf/d)
WEINMANN Medical Technology: Batteriepack MEDUCORE Easy
February 2017
Defibrillators, non-implantable
Model: Batteriepack MEDUCORE Easy; 40155
MHRA reference: 2017/002/016/291/011
Zimmer: All metal heads including: Modular femoral heads, Protasul S30 femoral heads and Metasul femoral heads
13 February 2017
Joint prosthesis, hip
Model: Modular femoral heads, Protasul S30 femoral heads, Metasul heads that can be used in a metal on polyethylene combination
MHRA reference: 2017/002/013/701/022