Field Safety Notice: 16 to 20 September 2019
List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 September 2019.
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 the latest
Abbott: Alinity
16 September 2019
IVDs, clinical chemistry
MHRA reference:
Axis-Shield: Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT
16 September 2019 IVDs, clinical chemistry Model: FHRWR100/200/1000 and FHBC100 MHRA reference:
Baxter: PrisMax, V2, ROW
14 August 2019
Dialysis, haemodialysis
Model: 955558
MHRA reference:
Bio-Rad: DC-Screening II
11 September 2019
IVDs, blood transfusion
Model: 50560
MHRA reference:
Boston Scientific: iLab鈩� Polaris Multi-Modality Guidance System
18 September 2019
Ultrasound, imaging
Model: H749009710
MHRA reference:
Cordis: Cordis庐 POWERFLEX庐 PRO PTA Dilatation Catheter
23 August 2019
Vascular cannula and catheters
MHRA reference:
Edwards Lifesciences: EV1000A / EV1000N
FCA-128
Monitors, patient
MHRA reference:
Johnson & Johnson: 1-DAY ACUVUE庐 MOIST庐for ASTIGMATISM Contact Lenses
September 2019
Contact lenses & shells
MHRA reference:
Maquet (Getinge):
11 September 2019
Infusion & transfusion, heart lung circuits 701067941, 701067942, 701067948, 701067949, 701067951, MHRA reference:
Medtronic: Adapta鈩�, Versa鈩�, Sensia鈩�, Relia鈩�, Attesta鈩�, Sphera鈩�, and Vitatron鈩� A, E, G, Q series Implantable Pulse Generators (IPG) (UPDATE TO FSN 21-25 JANUARY 2019)
September 2019
Implants, active, pacemakers
Model: Distributed between 10 March 2017 and 7 January 2019
MHRA reference:
MGB Endoskopische Gerate: GRP handle (with ratchet)
19 February 2019
Surgical instruments, minimal access
Model: 429-77015, 429-77015N, 429-77020, 429-77020N, 429-77030, 429-77030N
MHRA reference:
Ortho-Clinical: VITROS Chemistry Products CL- & K+ Slides
September 2019
IVDs, clinical chemistry
MHRA reference:
World of Medicine: Aquilex Fluid Control System
17 August 2019
Infusion systems
Model: AQL-100CBS
MHRA reference: