Field Safety Notice - 12 to 16 March 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 March 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
Abbott: Alinity hq Analyzer
23 February 2018
IVDs, haematology
MHRA reference: 2018/003/002/478/016
Arjo: Maxi Sky 2 - scales 700-19490 and 700-19485
28 February 2018
Hoists and slings
Model: Product code: 700-19485 & 700-19490
MHRA reference: 2018/002/008/601/001
Biomet Orthopedics (Zimmer): Bone Cement
22 January 2018
Bone cement and tools
MHRA reference: 2017/011/015/291/035
CIVCO Medical Instruments: Infiniti Bracket
26 February 2018
Surgical instruments, minimal access
Model: 639-026, 698-009, 698-016, 620-116
MHRA reference: 2018/003/009/478/013
DiaMed (BioRad): IH-1000
13 March 2018
IVDs, blood transfusion
001000
MHRA reference: 2018/003/015/228/005
Fresenius Kabi: VLST00 standard
15 March 2018
Infusion & transfusion, administration sets
MHRA reference: 2018/001/024/401/006
Gambro Dialysatoren (Baxter): U9000
March 2018
Dialysis, haemodialysis
Model: 112062
MHRA reference: 2018/003/013/478/002
Halyard Health: Halyard* Closed Suction System
07 February 2018
Suction equipment
MHRA reference: 2018/003/009/478/014
MICREL MEDICAL DEVICES SA: RYTHMIC EVOLUTION
12 March 2018
Infusion systems
MHRA reference: 2018/003/014/478/014
Maquet Critical Care AB: Servo-i, Servo-s, Servo-u, Servo-n, Servo-air
27 February 2018
Lung ventilators
Model: 6487800, 6640440, 6694800, 6688600, 6882000, 6884905
MHRA reference: 2018/003/008/478/003
Maquet Getinge Group: OTESUS OR table column, mobile
14 March 2018
Operating table
116001C0, 116001D0
MHRA reference: 2018/003/015/228/004
Micro Therapeutics, lnc. DBA ev3 Neurovascular: MindFrame CaptureTM LP
March 2018
Infusion & transfusion, administration sets
Model: 300010, 300011, 300012, 300013
MHRA reference: 2018/003/012/478/003
Preservation Solutions: Belzer UW Cold Storage Solution 2 Liter
09 March 2018
Storage & collection devices
MHRA reference: 2018/003/009/601/019
Radiometer: TCM5 FLEX/TCM5 BASIC
March 2018
Diagnostic measurement and monitoring
MHRA reference: 2017/010/012/291/008
Rocialle: Vascular Insertian Pack
09 March 2018
Surgical devices, non-powered
MHRA reference: 2018/003/013/228/014
Smith & Nephew: PERI-LOC K-WIRE 1.6MM X 150MM LENGTH TROCAR POINT
09 March 2018
Surgical instruments, minimal access
MHRA reference: 2018/003/014/478/016
Stryker: T5 Toga
March 2018
Surgical mask
MHRA reference: 2018/003/012/478/006
Torbay Pharmaceuticals: Sterile Eye Dropper
12 March 2018
Surgical devices, non-powered
U5134G
MHRA reference: 2018/003/006/601/003