Field Safety Notices: 12 to 16 August 2024
List of Field Safety Notices from 12 to 16 August 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
Abiomed: Impella 5.5; Impella CP® (both with SmartAssist®)
31st July 2024
Intracardiac Circulatory Assist Axial Pump Catheter
Model: 0550-0007; 2000193; 2000154
MHRA reference: 31519559
BAUERFEIND: Various products of: medical compression stockings
1st July 2024
30877, 36206, 41031, 41065, 41053, 41458, 12101
MHRA reference: 31438788
BioMérieux : BIOFIRE TORCH & BIOFIRE FILMARRAY 2.0
August 2024
Bloodstream infection-associates microorganism nuc
Model: FLM2-ASY-0001 & FLM2-ASY-0001-W (FILMARRAY 2.0), HTFA-ASY-0003 & HTFA-ASY-0003-W (TORCH), 423483 & 423483-W (FILMARRAY 2.0 Industry)
MHRA reference: 31502215
MHRA reference: 31502215
Fresenius Medical Care: stay safe Disinfection Cap
25th September 2023
Vascular catheter protective cap
MHRA reference: 31484966
Medtronic: MiniMed 640G Insulin Pump, MiniMed 700 SERIES
August 2024
Model: See FSN
MHRA reference: 31448456
MHRA reference: 31448456
MHRA reference: 31448456
Medtronic: See attached (Multiple)
March 2024
See attached (Multiple)
MHRA reference: 31479215 - Customer acknowledgement form
MHRA reference: 31479215
Medstrom: Solo
30th August 2023
Basic electric hospital bed
Model: All Solo beds with split side rails
MHRA reference: 31514447
Philips: Philips Azurion System
6th August 2024
Stationary general-purpose fluoroscopic x-ray
Model: 722079, 722224
MHRA reference: 31478324
Smiths Medical: BLUSelect®, BLUgriggs® and BLUperc® Trach products
15th August 2024
Tracheostomy tube, non-reinforced, non-customized
Model: See Affected Products List
MHRA reference: 31481726
Smith & Nephew: REGENETEN Tendon Anchors
12th August 2024
MHRA reference: 31515143
Werfen: HemosIL AcuStar ADAMTS13
August 7th 2024
ADAMTS13 activity IVD, kit, chemiluminescent imm
MHRA reference: 31458079