Field safety notices - 8 to 12 February 2016

List of field safety notices (FSNs) from medical device manufacturers from 8 February to 12 February 2016.


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

AcuFocus: KAMRA Corneal Inlay ACI 7000

February 2016

Implants, Non active, Intraocular

MHRA reference: 2016/002/009/292/007


2 February 2016

Vascular cannula/catheter accessories

Model: 2064-HQS-1 OF-1 00

2064-HQS-16F-140, 2064-HQS-16F-300, 2064-HQS-18F-140, 2064-HQS-18F-200,

2064-HQS-18F-300, 2064-HQS-20F-140, 2064-HQS-20F-200, 2064-HQS-20F-300,

2064-HQS-22F-140, 2064-HQS-22F-300, 2064-HQS-24F-140, 2064-HQS-26F-140

MHRA reference: 2016/002/005/291/005

Applied Medical: CA500, Epix® Universal Clip Applier 3/BX

28 December 2015

Clip appliers Model: CA500

MHRA reference: 2016/002/010/292/001

Arrow International: Arrow Pressure Injectable PICC Kit with Blue FlexTip Catheter

1 February 2016

Vascular cannula and catheters

MHRA reference: 2016/002/002/292/008


10 February 2016

IVDs, viral microbiology

MHRA reference: 2016/002/010/291/001

Coloplast: SpeediCath Compact Eve

10 February 2016

Urinary catheters and accessories

Model: 281100, 281140

MHRA reference: 2016/002/010/292/009



Magnetic resonance, equipment & accessories

MHRA reference: 2016/002/011/601/001

Endologix: Nellix EndoVascular Aneurysm Sealing System N10-100, N10-110, N10-120, N10-130, N10-140, N10-150, N10-160, N10-170, N10-180, NP-002; NP-001; NP-003; NP-005; NX-001


Implants, Non active, Endoprostheses for aortic aneurysms

MHRA reference: 2016/002/010/601/014

Gambro: 115244: AK 98, 230V, Efficient, 115248: AK 98,230V, Bio Version, 115249: AK 98,115V, Bio Version, 115250: AK 98, 230V, Self-Care, 115251: AK 98,115V, Self-Care

February 2016

Dialysis, Haemodialysis

MHRA reference: 2016/002/008/291/005

Genesee: Curved Sternal Retractor

28 December 2015

Surgical Instruments, articulated retracting

Model: Sternal Retractors: SRCL-AR, SR-SBL, SR-DBL, CSR-CB, CSR-SB, PSR-SB, PSR-NB and NSR-CR.

MHRA reference: 2015/012/031/291/001

Haemonetics: ACP215 Automated Cell Processor · MCS+9000 Mobile Platelet Collection System · MCS+8150 Multicomponent Collection System · PCS2 Plasma Collection

December 2015

Apheresis MHRA reference: 2016/002/003/291/006

Leonhard Lang GmbH: multifunction defibrillation electrode

8 February 2016

Defibrillators, non-implantable

Model: Various Models

MHRA reference: 2016/002/008/292/008

Pennine Healthcare: Basic Arthroscopy Pack - Uromatic TUR Admin. Set

5 February 2016

Surgical devices, non-powered

Model: Basic Arthroscopy Pack - Uromatic TUR Admin. Set

MHRA reference: 2016/001/028/291/001

Philips Medical: QLAB

5 November 2014

Picture Archiving and Communication System (PACS)

Model: QLAB 10.0 and 10.1.x

MHRA reference: 2016/002/004/292/005

Physio-Control: see section 8 for full name

February 2016

Defibrillators, Non Implantable

Model: ADULT-EDGE Electrode with QUIK-COMBO Connector and REDI-PAK Preconnect

MHRA reference: 2016/002/010/701/011

Radiometer Medical

FAN 915-347

IVDs, clinical chemistry

Model: AQT90 FLEX Test Kit Box and CAL Cartridge

MHRA reference: 2016/002/008/292/007

Roche: cobas p 512 pre-analytical system

4 February 2016

IVDs, clinical chemistry

MHRA reference: 2016/002/009/701/010

Richard Wolf: Flexion·Port

3 February 2016

Trolleys and chairs

Model: 32116068, 3,2116093, 321161 03

MHRA reference: 2016/002/008/292/002

Siemens: ACS: 180/ADVIA Centaur Calibrator E 42786

February 2016

IVDs, clinical chemistry

MHRA reference: 2016/002/005/601/002

Sorin Group: Various - see attached

4 February 2016

Infusion & transfusion, heart lung circuits

MHRA reference: 2016/002/005/291/002

Synthes: Screw Inserter for TFN-Advanced™ (TFNA) Proximal Femoral Nailing System

21 October 2015

Surgical Instruments, Implant

MHRA reference: 2016/002/011/292/001

Thermofisher Scientific: Oxoid Streptococcal Grouping Kit

9 February 2016

IVDs, bacteriology

Model: DR0585A

MHRA reference: 2016/002/010/601/008

Varian Medical Systems

8 February 2016


Model: Varian Trilogy

MHRA reference: 2015/002/011/401/014

Z-Medica: QuikClot Combat Gauze Z-Fold

1 February 2016

Implants, Non active, vascular haemostasis device

Model: 200 / 375

MHRA reference: 2016/002/009/292/002

Zimmer Spine: Endobon ROX

1 February 2016

Implant materials, bone substitutes

MHRA reference: 2016/001/018/292/017

Published 15 February 2016