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