Field Safety Notice - 06 to 10 November 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 6 to 10 November 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
Boston Scientific: ELUVIA™ Over the Wire Drug-Eluting Vascular Stent System
Innova ™ Over the Wire Self-Expanding Stent System
November 2017
Implants, non active, peripheral vascular
Model: ELUVIA: H74939295601570, H74939295601510, H74939295701570, H74939295701510 Innova: H74939180051870, H74939180052070, H74939180061870, H74939180062070, H74939180071870, H74939180072070, H74939180081870, H74939180082070, H74939181051830, H74939181052030, H74939181061830, H74939181062030, H74939181071830, H74939181072030, H74939181081830, H74939181082030
MHRA reference: 2017/011/008/228/007
Cook Medical: Wills-Oglesby Percutaneous Gastrostomy Set
19 October 2017
Feeding systems and tubes
MHRA reference: 2017/010/030/291/006
DiaSys Diagnostic Systems GmbH: Urea Test Strips
02 November 2017
IVDs, Clinical Chemistry
Model: N/A
MHRA reference: 2017/011/007/701/032
Elekta: Integrity
November 2017
Radiotherapy
MHRA reference: 2017/011/008/228/005
Elekta: Agility 3.2
November 2017
Radiotherapy
Model: Agility with Integrity
MHRA reference: 2017/011/008/228/006
ICU Medical: Hospira MedNet ™ Medication Management Suite
31 October 2017
Standalone diagnostic workstation
Model: 16037-75-01 and 16037-75-02
MHRA reference: 2017/010/019/291/003
Mediplus Ltd.: Silicone 2 Way Foley Catheter Kit, 16Fr
13 October 2017
Urinary catheters and accessories
Model: 5779
MHRA reference: 2017/011/006/701/014
Spiegelberg: External Lumbar Drainage Catheter
15 February 2016
Cerebrospinal fluid drainage, external
Model: External Lumbar Drainage Catheter ELD33.010.02
MHRA reference: 2016/009/008/299/004
Zimmer: Hex Driver, 2.5 mm with GemLock® Retention
19 October 2017
Dental appliances / instruments
MHRA reference: 2017/010/018/291/014