Field safety notices - 27 to 31 July 2015
List of field safety notices (FSNs) from medical device manufacturers from 27 to 31 July 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
Amanta Healthcare: Hypromol eye drops BP (sterile hydroxy propyl methyl cellulose (HPMC) Eye drops)
22 July 2015
Topical ophthalmic substances
MHRA reference: 2015/007/028/291/003
Amanta Healthcare: CLINIPOD (sterile normal saline topical irrigation solution)
22 July 2015
Surgical equipment, miscellaneous
MHRA reference: 2015/007/028/291/004
Becton Dickinson Diagnostics BD CD56 PE-Cy7
17 July 2015
IVDs, viral microbiology
Model: 335826
MHRA reference: 2015/007/024/601/005
Immunodiagnostic Systems: IGF-1 NEXT IRMA CT
30 December 2014
IVDs, clinical chemistry
Model: insulin-like growth factor-1 (IGF-I) IRMA
MHRA reference: 2015/001/005/081/004
Integral Medical Products Co: fannin integral silicone laryngeal mask - standard
24 July 2015
Laryngeal mask airway
Model: LM2010S2
MHRA reference: 2015/007/027/291/011
Iris International: iChem velocity automated urine chemistry system
15 July 2015
IVDs, clinical chemistry
MHRA reference: 2015/007/028/601/009
Leica Biosystems: ASP300S (14047643515)
28 July 2015
IVDs, cytopathology & histopathology
MHRA reference: 2015/007/028/291/006
Medtronic Activa PC Neurostimulator, Activa SC multi-program neurostimulator, Activa PC+S, Activa RC multi-program rechargable neurostimulator, Soletra and Kinetra
July 2015
Implants, active, stimulators, neuro
Model: 37601, 37602, 37603, 37604, 37612, 7426 and 7428
MHRA reference: 2015/007/027/291/002
Nihon Kohden: central monitor CNS-6201
June 2015
Monitors, patient
MHRA reference: 2015/007/024/292/002
Nipro: Sureflux: SUREFLUX 25UX LC GA
23 July 2015
Dialysis, haemodialysis
MHRA reference: 2015/007/024/292/016
Philips Healthcare: 722010, 722011, 722012, 722013, 722022, 722023, 722024, 722025 and all other eventual model numbers mentioned on the unit affected list
10 July 2015
X ray, fluoroscopy systems
Allura Xper Systems,
MHRA reference: 2015/007/029/291/020
Vascular Solutions: TurnPike catheter
09 July 2015
Vascular cannula and catheters
Model: 5621, 5630, 5640, 5641
MHRA reference: 2015/007/027/291/017
Vygon: Ipswich ANTT adult cannulation pack
29 July 2015
Vascular cannula and catheters
Model: 0P6193255PHA
MHRA reference: 2015/007/029/601/003