Field safety notices - 27 to 31 July 2015

List of field safety notices (FSNs) from medical device manufacturers from 27 to 31 July 2015.


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

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

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