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

View the 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

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