Field Safety Notices: 10 to 14 April 2023
List of Field Safety Notices (FSNs) from 10 to 14 April 2023.
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
Altomed: Tonosleeve
30 March 2023
Ophthalmic tonometer tip cover
Model: A10036/300
MHRA reference: 5153508
Beckman Coulter: Bicarbonate
07 April 2023
Bicarbonate (HCO3-) IVD, kit, enzyme spectrophotom
MHRA reference: 5154180
Medartis: Orbital retractor, right; Orbital retractor, left
29 March 2023
MHRA reference: 5151406
Medtronic: Hugo RAS Arm Cart Assembly
April 2023
ROBOT-ASSISTED ENDOSCOPIC SURGERY SYSTEMS
Model: MRASC0002
MHRA reference: 5152439
Siemens Healthineers: ADVIA Chemistry ToxAmmonia Calibrator
April 2023
Calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator
MHRA reference: 5153720
Siemens Healthineers: Stratus CS Acute Care D-dimer Calibrator
March 2023
D-dimer IVD, kit, fluorescent immunoassay
MHRA reference: 5151408
Smiths Medical: Jelco Optiva IV Catheter 5063-AI
13 April 2023
MHRA reference: 5151355