Field Safety Notice - 16 to 20 April 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 April 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
Arrow International (Teleflex Medical)
12 April 2018
Vascular cannula and catheters
MHRA reference: 2018/004/013/478/010
BioFire Diagnostics: FilmArray Blood Culture Identification (BCID) Pan
03 March 2018
IVDs, bacteriology
MHRA reference: 2018/003/026/701/019
Chalice Medical: Paragon
16 January 2018
Infusion & transfusion, heart lung circuits
PMP Oxygenators
MHRA reference: 2018/001/030/601/003
Cook Medical: Soft-Trans Embryo Transfer Catheter
11 April 2018
Laboratory equipment associated with IVF, cells, tissues
MHRA reference: 2018/004/016/701/016
Covidien / Medtronic: EEA™ Hemorrhoid and Prolapse Stapler Set with DST Series™ Technology
April 2018
Staples and staple guns
Model: HEM3335, HEM3348
MHRA reference: 2018/004/016/291/004
Draeger Medical Systems: Jaundice Meter JM-103
March 2018
Diagnostic measurement and monitoring
MHRA reference: 2018/004/016/291/008
Draeger Medical Systems: Infinity Acute Care System (M540)
March 2018
Monitors, patient
MHRA reference: 2018/004/019/291/002
Draeger Medical Systems: Jaundice Meter JM-105
March 2018
Diagnostic measurement and monitoring
MHRA reference: 2018/004/017/291/014
GE Healthcare: Innova IGS620/630/520/530/540; Discovery IGS730/740
12266
X Ray, fluoroscopy systems
MHRA reference: 2018/004/016/478/003
IBL International: Progesterone Luminescence Immunoassay
17 April 2018
IVDs, clinical chemistry
MHRA reference: 2018/004/018/701/016
JRI Orthopaedics
16 April 2018
Joint prosthesis, hip
Aeon ref 0420012
MHRA reference: 2017/005/018/401/018
MRC-Holland: SALSA MLPA Probemix P060 SMA
02 April 2018
Instrumentation/ platform
MHRA reference: 2018/004/003/701/004
Randox Laboratories: RX Imola
06 April 2018
IVDs, clinical chemistry
RX4900, RX4900R
MHRA reference: 2018/004/017/601/005
Schiller: Cardiovit AT-102 plus
10 April 2018
ECG
MHRA reference: 2018/004/019/701/008
Thermofisher Scientific: Thermo Scientific™ Oxoid™ Brilliance™ Salmonella Agar Base, CM1092B&T
20 February 2018
IVDs, bacteriology
MHRA reference: 2018/003/020/601/003
Zimmer: Segmental System Proximal Femoral Component 38mm
13 April 2018
Joint prosthesis, hip
MHRA reference: 2018/004/016/478/001