Field Safety Notice - 30 October to 3 November 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 30 October to 3 November 2017.
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
Abbott: Alinity hq Analyzer
26 October 2017
IVDs, heamatology
MHRA reference: 2017/010/031/291/015
DePuy International Ltd: Acetabular Cup Introducer
31 October 2017
Orthopaedic surgical instruments - insertion/extraction tools
Model: 962636000
MHRA reference: 2017/010/030/291/005
Draeger: Fabius GS/ GS premium/ MRI/ Plus/ Plus XL/ Tiro
October 2017
Anaesthetic machines & monitors
MHRA reference: 2017/011/001/291/002
Fukuda Densh UK: Dynascope
16 October 2017
Monitors, patient
Model: DS 8100
MHRA reference: 2017/010/027/601/010
GE: Carestation 620, Carestation 650, Carestation 650c
October 2017
Anaesthetic machines & monitors
MHRA reference: 2017/010/025/701/026
HTL-Strefa: Microdot Droplet Pen Needle 4mm x 32G
12 October 2017
Insulin injection devices
Model: Microdot Droplet Pen Needle 4mm x 32G 810
MHRA reference: 2017/010/023/291/010
Johnson & Johnson: 1-DAY ACUVUE® MOIST Brand Contact Lenses
25 October 2017
Contact lenses & shells
MHRA reference: 2017/010/027/291/008
Johnson & Johnson: ACUVUE® OASYS®, ACUVUE® ADVANCE®, ACUVUE MOIST® for Astigmatism
26 October 2017
Contact lenses & shells
MHRA reference: 2017/010/027/291/025
Johnson & Johnson Vision Care, Inc.: ACUVUE® OASYS® for ASTIGMATISM
26 October 2017
Contact Lenses & Shells
Model: N/A
MHRA reference: 2017/010/030/291/001
LivaNova
24 October 2017
Heart lung machines
Model: CP5 CENTRIFUGAL PUMP, 60-00-60
MHRA reference: 2017/010/025/701/023
Maquet: SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Cath
17 October 2017
Cardiac assist pumps
Model: SENSATION PLUS® 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK®
MHRA reference: 2017/010/023/291/011
Maquet: Heater Cooler Unit HCU20; Heater Cooler Unit HCU30
26 October 2017
Blood/fluid warming systems
Model: 70101.0892; 70101.0895; 70101.0896; 70102.8717; 70101.7239; 70102.2333; 70102.2336; 70102.8718; 70103.4642; 70103.4653;70103.4371
MHRA reference: 2017/010/030/291/002
Medline
27 October 2017
Surgical equipment, miscellaneous
Model: Soft suction liner 3000cc/ml (with tube / Med-Gel)
MHRA reference: 2017/010/030/291/018
Oculentis BV: LENTIS
27 October 2017
Implants, non active, intraocular
Model: LENTIS - All models starting with L or LS or LU
MHRA reference: 2017/009/013/291/009
Smith & Nephew: Legion HK Tibial Base
October 2017
Joint prosthesis, knee
MHRA reference: 2017/010/031/291/017
Stanmore: METS Principal Shaft
26 October 2017
Joint prosthesis, knee
Model: msfshft/150
MHRA reference: 2017/010/030/291/003
Stryker: Thoracic Pedicle Feeler
16 October 2017
Surgical navigation system
Model: Thoracic Pedicle Feeler
MHRA reference: 2017/010/027/291/020
Stryker: rHead® System Radial Head Arthroplasty / Uni Elbow
October 2017
Joint prosthesis, elbow
MHRA reference: 2017/010/016/701/063