Field Safety Notices - 3 - 7 October 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 3 - 7 October 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
Alphatec Spine: Aresnal Spinal Fixation System
29 September 2016
Spinal implants
Model: 47127
MHRA reference: 2016/010/003/601/001
Applied Medical Technology: Saflo™ 90 Needle Safe Subcutaneus Infusion Set
NF-2
Infusion & transfusion, administration sets
Model: 9mm catheter c/w 100cm tubing, Saflo™ 90 Needle Safe Subcutaneus Infusion Set
MHRA reference: 2016/008/012/401/008
Boston Scientific
3 October 2016
Implants, non-active, cardiac appendage and septal defect occluders / plugs
Model: M635WS50200, M635WS50240, M635WS50270, M635WS50310 & M635WS50350.
MHRA reference: 2016/003/029/292/014
Christoph Miethke: proGAV 2.0 Shuntsystem
29 September 2016
Implants, non-active, hydrocephalus shunts
Model: FX471T
MHRA reference: 2016/010/006/701/014
Covidien: Devon™ Light Glove
October 2016
Lamps & lights
MHRA reference: 2016/010/004/701/004
FUJIFILM: Fujifilm Flexible Ultrasonic Endoscope
ECN-G1609
Endoscopes, flexible
Model: EG-530UR2 & EG-530UT2
MHRA reference: 2016/009/030/291/001
FUJIFILM: Fujifilm Synapse PACS
30 September 2016
Picture Archiving and Communication System (PACS)
MHRA reference: 2016/010/005/299/003
GDF Gesellschaft für Dentale Forschung und Innovationen: Enamel plus HRi Compulen
14 September 2016
Dental materials
MHRA reference: 2016/008/005/701/025
GE Medical: MAC 600, MAC 800, MAC 1200, MAC 1600, MAC 2000, MAC 3500, MAC 5000, MAC 5500, MAC 5500 HD
FMI30080
ECG
MHRA reference: 2016/009/030/291/014
ICU Medical: Monitoring Kits with Transpac® IV Transducer
4 October 2016
Infusion and transfusion, administration sets
MHRA reference: 2016/010/006/701/005
Laerdal Medical
27 September 2016
Suction equipment
Model: Laerdal Suction Unit (LSU): LSU w/Serres I LSU w/Reusable I LSU wi Bemis I LSU wi Abbott
MHRA reference: 2016/007/018/291/012
Medivance: Arctic Sun® Temperature Management System
FA2016-47
Heating, patient, electrical pads & blankets
MHRA reference: 2016/009/022/601/008
Micro Therapeutics: Pipeline Embolization Device, Alligator Retrieval Device, Marathon Flow Directed Microcatheter, UltraFlow HPC Flow Directed Microcatheter, Xcelerator Hydrophillic Guidewire
October 2016
Vascular cannula/catheter accessories
MHRA reference: 2016/010/005/299/004
Mölnlycke Healthcare: ProcedurePak® kits and trays containing cohesive bandages (components 2303205-00 & 2301997-00)
29 September 2016
Bandages and tapes
MHRA reference: 2016/010/003/701/007
Occlutech: Occlutech LAA Occluder
30 September 2016
Implants, non active, cardiac appendage and septal defect occluders / plugs
Model: LAAv3.0
MHRA reference: 2016/010/003/291/021
Osteogenics Biomedical: Cytoplast Non-Resorbable Barrier Ti-250
28 September 2016
Implants, dental
MHRA reference: 2016/009/028/601/011
R & D Systems: Quantikine IVD Human sTfR Immunoassay
RE081616-DTFR1
IVDs, clinical chemistry
MHRA reference: 2016/009/028/291/012
Radiometer Medical: TCM5
FAN 915-354
Diagnostic measurement and monitoring
Model: TCM5
MHRA reference: 2016/009/019/701/013
Randox: CK NAC
26 September 2016
IVDs, clinical chemistry
Model: CK8313
MHRA reference: 2016/009/030/601/001
SentreHEART: FindrWIRZ Guide Wire System
30 September 2016
Vascular cannula/catheter accessories
MHRA reference: 2016/010/004/601/001
Siemens: Aptio Automation System
October 2016
IVDs, clinical chemistry
MHRA reference: 2016/010/006/601/002
Sorin: REPLY, ESPRIT, FACIL, KORA
29 September 2016
Implants, active, pacemakers
Model: REPLY Models D, DR, VDR, SR, CRT-P ESPRIT Models D, DR, S, SR FACIL Model DR (approved and distributed in Japan only) REPLY 200 DR, SR, REPLY 250 DR KORA 100 DR, SR KORA 250 DR, SR REPLY, ESPRIT, FACIL, KORA
MHRA reference: 2016/009/029/291/011
Stryker: LFIT Anatomic CoCr V40 Femoral Heads
RA2016-028
Joint prosthesis, hip
MHRA reference: 2016/009/028/701/006
Synovis Life Technologies: Vascu-Guard Peripheral Vascular Patch
September 2016.pdf
Implants, non-active, surgical vascular grafts and patches
MHRA reference: 2016/007/006/291/011
Vascular Solutions: Twin-Pass, Twin-Pass .023", and Twin-Pass RX Dual Access Catheters
2134812-09/20/2016-002R
Vascular cannula and catheters
Model: Twin-Pass, Twin-Pass .023", and Twin-Pass RX Dual Access Catheters 5200, 5210, 5230
MHRA reference: 2016/009/026/291/013
VYGON: LECTROGAURD
3 October 2016
Infusion & transfusion, administration sets
Model: 1188.15
MHRA reference: 2016/010/003/601/009
Welch Allyn: Connex Spot Monitor
WA16-01-01
Monitors, patient
Model: Connex Spot Monitor 7000-PS
MHRA reference: 2016/009/009/701/015