Field safety notices - 14 to 18 September 2015
List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 September 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
Blatchford Products: Endolite dynamic pylon top housing
2 September 2015
Prostheses
MHRA reference: 2015/009/010/291/001
CareFusion: Alaris syringe pump – (CC, GH, GS, PK and TIVA)
July 2015
Infusion systems
Model: various models
MHRA reference: 2015/009/011/292/012
Depuy Synthes: Sciatic nerve retractor
27 August 2015
Surgical instruments, implant
MHRA reference: 2015/009/015/081/008
MAKO Surgica: RIO base array
August 2015
Surgical navigation system
Model: RIO 2.x
MHRA reference: 2015/009/011/051/001
Medifab Medical Fabrication: Shuttle Discovery
07 September 2015
Supportive seating
Model: Product code – 2006-0010-000
MHRA reference: 2015/009/010/601/007
P3 Medical Ltd: Pro-Breathe
11 September 2015
Airway devices
Model: PBI314750
MHRA reference: 2015/009/011/601/011
P3 Medical: Armstrong Medical vented tracheal tube introducer with oxygen connector
14 September 2015
Airway devices
Model: INBV14750OX
MHRA reference: 2015/009/014/601/002
P3 Medical: vented tracheal tube guides (bougies)
10 September 2015
Airway devices
Model: 14750
MHRA reference: 2015/009/010/601/008
Pennine Healthcare: Laryngeal suction tube with soft tip
14 September 2015
Suction equipment
Model: NL-0025
MHRA reference: 2015/009/014/292/014
Roche Diagnostics: Accu-Chek Spirit Combo; Accu-Chek Spirit
SB_RDC_2015_02
Infusion systems
Model: Accu-Chek Spirit Combo: 00700006863; Accu-Chek Spirit: 00700006862.
MHRA reference: 2015/004/020/701/008
Roche Diagnostics: PVT bulk loader module (BLM)
09 September 2015
IVDs, clinical chemistry
MHRA reference: 2015/009/014/701/002
Smith & Nephew: MOSAICPLASTY DP – disposable harvesting system
11 September 2015
Surgical instruments, implant
MHRA reference: 2015/009/011/051/002
Thoratec Corporation: HeartMate II LVAS system controller
14 September 2015
Implantable ventricular assist devices
Model: 105109 (Pocket Controller)
MHRA reference: 2015/009/015/081/012
Zimmer: Zimmer natural nail CM long – cephalomedullary nails
14 September 2015
Osteosynthesis, nails intramedullary
MHRA reference: 2015/009/015/081/004
Zimmer:Trauma guide wire
16 September 2015
Vascular cannula/catheter accessories
MHRA reference: 2015/009/017/181/003