Field Safety Notices: 8 to 12 May 2023
List of Field Safety Notices (FSNs) from 8 to 12 May 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
Abiomed: Impella 5.5 with SmartAssist heart pump
17 April 2023
Intracardiac Circulatory Assist Axial Pump Catheter
Model: 0550-0007
MHRA reference: 5185967
B Braun: PROSET INFUSION SETs
12 April 2023
Intravenous Line Stopcock
MHRA reference: 5154165
Brandon Medical: Quasar eLite
27 February 2023
Operating light & Operating light system
MHRA reference: 5101386
Coloplast: Titan Inflatable Penile Prosthesis
23 February 2023
Inflatable Penile Prosthesis
MHRA reference: 5096764
FH ORTHO: BEPOD
20 April 2023
MHRA reference: 5203538
FUJIFILM medwork: Dilatation balloon (DIL1-A1-Series)
February 2023
Model: DIL1-A1-06-40-23-35
MHRA reference: 5119405
Galt: Tearaway Introducer Set
10 May 2023
Vascular catheter introduction set non-implantable
MHRA reference: 5224184
Helena Biosciences: Collagen
10 March 2023
Platelet aggregation study IVD, reagent
Model: 5368, O863510
MHRA reference: 5114030
Immucor GTI Diagnostics: LIFECODES HLA-DQA1/B1 SSO Typing Kit – Customer Letter
21 April 2023
DNA-based tissue typing IVD, kit, NAT
Model: 628930
MHRA reference: 5194585
Immucor GTI Diagnostics: LIFECODES HLA-DQA1/B1 SSO Typing Kit – Distributor Letter
21 April 2023
DNA-based tissue typing IVD, kit, NAT
Model: 628930
MHRA reference: 5194587
Maxtec: Handi+ Oxygen Analyzer
20 April 2023
Analyzer, Gas, Oxygen
Model: Handi+ ; Part No: R218P12-001
MHRA reference: 5229283
Medtronic: Shiley Adult FlexibleTracheostomy Tube
March 2023
Tracheostomy tube, non-reinforced, non-customized
Model: 4CN65A, 4CN65R, 4UN65A, 4UN65R, 5CN70A, 5CN70R, 5UN70A, 5UN70R, 6CN75A, 6CN75R, 6UN75R, 7CN80A, 7CN80R, 7UN80A, 7UN80R, 8CN85A, 8CN85R, 8UN85A, 8UN85R, 9CN90R, 9UN90R, 10CN10R, 10UN10A, 10UN10R
MHRA reference: 5145668
Medtronic: Cobalt XT, Cobalt, Crome Implantable Cardioverter/Defibrillator Systems - Viva™ and Brava Cardiac Resynchronization Therapy-Defibrillation (CRTD) Devices - Evera Implantable Cardioverter-Defibrillator (ICD) Devices - Evera MRI SureScan Implantable Cardioverter Defibrillator (ICD) Devices - Visia AF and Visia AF MRI SureScan Single Chamber (VR) Implantable Cardioverter-Defibrillator (ICD) Devices - Primo MRI and Mirro MRI SureScan Implantable Cardioverter-Defibrillator (ICD) Devices - Claria MRI, Amplia MRI, Compia MRI CRT-D implantable cardioverter defibrillator with cardiac resynchronization therapy and SureScan Technology
May 2023
MHRA reference: 5231482
Randox: Specific Protein Control Levels 1-3
22 November 2022
Multiple clinical chemistry protein IVD, control
MHRA reference: 5119933
Stago: STAR MAX, STA-R EVOLUTION, STA COMPACT/COMPACT MAX
08 March 2023
Laboratory coagulation analyser IVD, automated
MHRA reference: 5099961
Stryker: METSTM Integral Shaft & Stem
April 2023
MHRA reference: 5230634