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.
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
AcuFocus: KAMRA Corneal Inlay ACI 7000
February 2016
Implants, Non active, Intraocular
MHRA reference: 2016/002/009/292/007
ALCIS: HQS
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
BIOMERIEUX: VIDAS TOXO IgM
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
NeoCoil
FSCA0146
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
FS-003
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
Radiotherapy
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