Field Safety Notice - 10 April to 14 April 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 10 - 14 April 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
View the latest FSNs
ANADOLU TIP TEKNOLOJILERI: FOCUS FORCE Aspheric Intraocular Lens
002/AS60130/17.00
Implants, non active, intraocular
MHRA reference: 2017/001/024/291/016
Arrow International: Arrow Pressure Injectable PICC Kit
10 April 2017
Vascular cannula and catheters
Model: Arrow Pressure Injectable PICC Kit; various makes and models
MHRA reference: 2017/004/010/299/025
Bard: MR GHIATAS® Beaded Breast Localization Wire
FA2017-10
Surgical devices, non-powered
MHRA reference: 2017/004/005/601/006
Medicina: 5ml Luer Lock IV Syringe
03 April 2017
Injection devices
Model: IVL05
MHRA reference: 2017/004/004/601/003
Möller-Wedel: CU 5001/3 und CU 3-21/23(Pilot run 14 devices)
February 2017
Surgical equipment, miscellaneous
MHRA reference: 2017/003/001/291/003
Phagenesis: Phagenyx
April 2017
Therapy, electrotherapy
Model: EPSA
MHRA reference: 2017/004/010/701/023
Siemens: RAPID Point ®500 Blood Gas Analyzer
April 2017
IVDs, extra laboratory testing
MHRA reference: 2017/004/010/601/007
Smirthwaite: Bath Chair
05 April 2017
Bath and aids
Model: 7607
MHRA reference: 2017/004/006/601/003
Sorin Group (LivaNova): Ovatio / Paradym / Paradym 2 / Paradym RF / Intensia devices
11 April 2017
Implants, active, defibrillators
Model: See FSN
MHRA reference: 2017/004/010/299/006
Taizhou Xinkang Medical Materials: Wound Dressing
23 March 2017
Basic dressings, absorbents, swabs
Model: NO.8, NO.9, NO.3
MHRA reference: 2017/004/007/299/025
Waters: ACQUITY UPLC Sample Organizer, IVD
10 April 2017
IVDs, clinical chemistry
Model: ACQUITY UPLC Sample Organizer, 186015020IVD
MHRA reference: 2017/004/007/299/018
bioMérieux: ETEST® ETP32 (Ertapenem)
7 April 2017
IVDs, bacteriology
MHRA reference: 2017/004/012/299/006