Field Safety Notices: 15 to 19 July 2024
List of Field Safety Notices from 15 to 19 July 2024.
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Andersen Caledonia: SP Eye Sharps Safe Intravitreal Injection Needle
16 July 2024
MHRA reference: 31235759
Beckman Coulter: DxI 9000 Access Immunoassay Analyzer
12 July 2024
Chemiluminescent Immunoassay analyser IVD
C11137
MHRA reference: 31234326
MHRA reference: 31234326
Biotech: iVascular sergeant 18
18 July 2024
Peripheral angiography devices,
Model: DSP18
Lot manufactured before 2024-05-14
MHRA reference: 31530001 2024/007/023/601/074
Boston Scientific: WAVEWRITER ALPHA IPG KIT-WAVEWRITERALPHA 16IPG KIT
17 July 2024
please refer to section 8
Model: SC-1216 and SC-1232
MHRA reference: 31234955
Bruker: UMIC Colistin
11 July 2024
Antibacterial minimum inhibitory concentration IVD
MHRA reference: 31190956
Change Healthcare: Change Healthcare Cardiology
July 2024
Information system, cardiology
14.0, 14.1.1,14.2 ,14.3, 14.3.2, 15.0.1
MHRA reference: 31190985
Exmoor: Aural Ventilation Tubes
15th July 2024
Model: E104 Shepards Drain without wire 0.97 mm E106 Collar Button 1.14 mm
MHRA reference: 31218724
Exmoor: Silicone Sheets, Discs and Strips
15 July 2024
Surgical anti-adhesion material, nonimplantable
E201 E202 E204 SRS1 SRS1A
MHRA reference: 31237622
INNOMED, INC: Cup Removal Starter Instrument-54MM
17 July 2024
5200-54
MHRA reference: 31233671
QuidelOrtho: VITROS XT Chemistry Products ALB-TP Slides
10 July 2024
Multiple-type clinical chem analyte IVD, reagent
MHRA reference: 31215093
MHRA reference: 31215093
Robinson Healthcare: Fast Aid Zinc Oxide Tape
17 July 2024
Flexible non-stretch support tape with a high tack adhesive, pressure bandage, non, latex, single use
Model: Refer to FSN
MHRA reference: 33951164 2024/007/017/601/052
werfen: NOVACLONE™ Anti-D IgM + IgG Monoclonal Blend
15 July 2024
Anti-Rh(D) red blood cell grouping IVD, antibody
MHRA reference: 31214989