Field Safety Notices: 13 to 17 March 2023
List of Field Safety Notices (FSNs) from 13 to 17 March 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
Abbott: FreeStyle LibreLink App, FreeStyle Libre 3 App/ HCP Resolution Letter FSLL Resolved FSL3 Pending
23 February 2023
Invasive Interstitial-fluid glucose monitoring system
MHRA reference: 5099927
NEW
Athrodax Healthcare International: I.B.S 3.0-C Compression screw - diam 3.0mm lg28mm
28 February 2023
Orthopaedic bone screw, non-bioabsorbable, sterile Model: S30 ST128
MHRA reference: 5100570
Belmont Medical Technologies: Rapid Infuser, RI-2 1000 ml/min,750 ml/min
24 February 2023
Infusion pump, high-flow, warming
Model: 903-00037A and 903-00039A
MHRA reference: 5090583
Biocartis: Idylla Instrument Test
14 March 2023
NUCLEIC ACID TESTING INTEGRATED EXTRACTION / AMPLI
MHRA reference: 5101652
Draeger: Infinity CentralStation, Infinity M300/M300+
March 2023
Physiological Monitoring Systems Model: MS18348, MS25707, MS32504, MS25755, MS26031, MS26076, MS33659, MS32504, MS33648
MHRA reference: 5101188
Full Vision: Trackmaster Treadmills
28 November 2022
MHRA reference: 5052085
Getinge: Cardiosave Intra-Aortic Balloon Pumps
8 February 2023
Circulatory assist system, intra-aortic balloon
Model: 0998-XX-0800-XX
MHRA reference: 5052013
Getinge: QUADROX-i/-iD | VHK 11000
13 March 2023
Oxygenator, extracorporeal membrane
MHRA reference: 5101657
GS Elektromedizinische Geräte G. Stemple GmbH: corpuls3
Technical Bulletin No. 023
Physiologic-monitoring defibrillation system Model: 04100, 04100.1, 04100.2, 04101, 04200, 04200.1, 04200.2, 04201, 04300, 04300.1, 04300.2, 04301, 04302, 04303, 04304, 04305
MHRA reference: 5101440
Iradimed: MRidium 1057 MRI Syringe Adapter Set
10 March 2023
MHRA reference: 5100797
Lavender Medical: I.B.S® 3.0-C Compression screw - diam 3.0mm lg28mm
28 February 2023
Orthopaedic bone screw, non-bioabsorbable, sterile
Model: S30 ST128
MHRA reference: 5100570
Podonics: Dispence Applicator – Phenol Blue 89%
22 February 2023
Model: PDP89B
MHRA reference: 5097902
Quidel: MicroVue C1-Inhibitor Plus EIA
27 January 2023
Model: A037
MHRA reference: 5101843
Radiometer: AQURE system
FAN 915-424
Model: 933-599
MHRA reference: 5094720
RESORBA: GENTA-COLL resorb, PARASORB RESODONT Forte, PARASORB RESODONT, GENTA-FOIL resorb, KOLLAGEN resorb
16 March 2023
MHRA reference: 5101618
Robinson Healthcare: Instrapac
11 January 2023
Tubular bandage applicator Model: Tubegauze Applicator (Medium)
MHRA reference: 5082085
Roche: cobas pure e 402 analytical unit, cobas e 801 analytical unit, cobas e 801 module, cobas pure sample supply unit, cobas pro sample supply unit, cobas pro SSU, cobas 8000 core unit
February 2023
MHRA reference: 5090801
Stryker: LIFEPAK CR2 Defibrillator
January 2023
MHRA reference: 5052023