Field Safety Notice – 30 October to 3 November 2017 – GOV.UK

September 26, 2021 by No Comments

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Summary List of field safety notices (FSNs) from medical device manufacturers from 30 October to 3 November 2017.
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.
View the latest FSNs
26 October 2017
IVDs, heamatology
MHRA reference: 2017/010/031/291/015
31 October 2017
Orthopaedic surgical instruments – insertion/extraction tools
Model: 962636000
MHRA reference: 2017/010/030/291/005
October 2017
Anaesthetic machines & monitors
MHRA reference: 2017/011/001/291/002
16 October 2017
Monitors, patient
Model: DS 8100
MHRA reference: 2017/010/027/601/010
October 2017
Anaesthetic machines & monitors
MHRA reference: 2017/010/025/701/026
12 October 2017
Insulin injection devices
Model: Microdot Droplet Pen Needle 4mm x 32G 810
MHRA reference: 2017/010/023/291/010
25 October 2017
Contact lenses & shells
MHRA reference: 2017/010/027/291/008
26 October 2017
Contact lenses & shells
MHRA reference: 2017/010/027/291/025
26 October 2017
Contact Lenses & Shells
Model: N/A
MHRA reference: 2017/010/030/291/001
24 October 2017
Heart lung machines
Model: CP5 CENTRIFUGAL PUMP, 60-00-60
MHRA reference: 2017/010/025/701/023
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
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
27 October 2017
Surgical equipment, miscellaneous
Model: Soft suction liner 3000cc/ml (with tube / Med-Gel)
MHRA reference: 2017/010/030/291/018
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
October 2017
Joint prosthesis, knee
MHRA reference: 2017/010/031/291/017
26 October 2017
Joint prosthesis, knee
Model: msfshft/150
MHRA reference: 2017/010/030/291/003
16 October 2017
Surgical navigation system
Model: Thoracic Pedicle Feeler
MHRA reference: 2017/010/027/291/020
October 2017
Joint prosthesis, elbow
MHRA reference: 2017/010/016/701/063
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