Field Safety Notice - 07 to 11 May 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 07 to 11 May 2018.

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

Alba Bioscience (Quotient): ALBAcyte®

07 May 2018

IVDs, blood transfusion

Model: Antibody Identification Cells (Native and Papainised)

MHRA reference: 2018/005/007/601/004

Armstrong Medical: ARMSTRONG MEDICAL

30 April 2018

Breathing system components

AMCP AND AMHO PREFIX PRODUCT CODES

MHRA reference: 2018/004/030/228/017

Biomet (Zimmer Biomet): ACE Trochanteric Nail (ATN) System

08 May 2018

Osteosynthesis, nails intramedullary

MHRA reference: 2018/005/008/228/002

Biomet (Zimmer Biomet): AIM Tibial Nail

04 May 2018

Osteosynthesis, bone screws

AIM Tibial Nail

MHRA reference: 2018/005/009/478/008

Caire (Chart)

23 April 2018

Laboratory equipment associated with IVF, cells, tissues

MHRA reference: 2018/005/004/478/001

Covidien (Medtronic): Endo GIA™ Articulating Loading Unit

May 2018

Staples and staple guns

Refer to table in FSN

MHRA reference: 2018/005/004/478/009

Ethicon

May 2018

Surgical power tools

MHRA reference: 2018/005/004/478/021

Euro Diagnostica: NEOLISA Chromogranin A

March 2018

Pregnancy Kit

MHRA reference: 2018/005/009/228/014

Heartware (Medtronic): HeartWare™ HVAD™ System

May 2018

Implantable ventricular assist devices

Controller - 1400, 1401, 1403, 1407, 1420 DC Adapter - 1435, 1440 AC Adapter - 1425, 1430 Battery Pack – 1650

MHRA reference: 2018/005/008/228/001

Hoya Corporation(Pentax Medical): PENTAX Flexible video duodenoscope

FSCA-PMJ-18-01-1

Endoscopes, flexible

ED-3490TK

MHRA reference: 2018/004/027/478/008

Hoya Corporation(Pentax Medical): PENTAX Flexible video duodenoscope

FSCA-PMJ-18-02-1

Endoscopes, flexible

ED34-i10T

MHRA reference: 2018/005/004/478/005

Kimal: Kimal Procedure Packs

03 May 2018

Surgical devices, non-powered

Model: DE-K34763, DE-K45957, CLFKITTP, EU-CPP-7F, EU-CLF-KITAC-TP, K63/0512W, K63/0712W

MHRA reference: 2018/005/004/601/006

Mercian Surgical Supply: KW7150-10

09 May 2018

Orthopaedic surgical instruments - measuring tools

MHRA reference: 2018/005/009/601/002

Olympus Medical Systems Corporation: EVIS DUODENOVIDEOSCOPE

02 May 2018

Endoscopes, flexible

OLYMPUS PJF TYPE 240

MHRA reference: 2018/005/004/228/003

Origen Biomedical: 100% DMSO syringe

08 May 2018

Storage & collection devices

MHRA reference: 2018/003/007/291/013

Otto Bock: Orthotic Adult aluminium option lock knee joint

04 April 2018

Orthoses

17KL40=16

MHRA reference: 2018/005/009/478/009

ReWalk Robotics Ltd: ReWalk Personal 6.0

August 2017

Therapy, standing & walking

MHRA reference: 2018/005/009/228/019

Roche Diagnostics: Accu-Chek® Aviva, Aviva Plus, Performa, SmartView and Inform II test strips

May 2018

IVDs, self / home testing

MHRA reference: 2018/005/004/228/002

SAM Medical Products: SAM XT Extremity Tourniquet

01 May 2018

Surgical equipment, tourniquets

SAM XT-B, SAM XT-C, SAM XT-M

MHRA reference: 2018/005/003/601/011

Smiths Medical: Elcam, Inc

09 May 2018

Infusion & transfusion, connectors

089-101E

MHRA reference: 2018/005/009/228/015

Thermo Fisher Scientific: Remel

26 April 2018

IVDs, bacteriology

R30161201 (ZD15), R30161301 (ZD16) and R30161401 (ZD17)

MHRA reference: 2018/005/001/601/002

Vital Healthcare: Tubing Sets for Hemodialysis / NovaLine®

April 2018

Dialysis, blood lines

BL 208 / BL 207 / BL 211 SN / BL 200 HDF / BL 245

MHRA reference: 2018/005/002/601/001

Vygon (UK) Ltd: 5FG Seldinger Technique 7cm Sheath

04 May 2018

Vascular cannula and catheters

G1146-057

MHRA reference: 2018/005/004/601/005

Published 14 May 2018