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 FSNs
Abbott: Alinity
16 September 2019
IVDs, clinical chemistry
MHRA reference: 2019/009/018/701/017
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: 2019/009/019/601/001
Baxter: PrisMax, V2, ROW
14 August 2019
Dialysis, haemodialysis
Model: 955558
MHRA reference: 2019/008/015/487/029
Bio-Rad: DC-Screening II
11 September 2019
IVDs, blood transfusion
Model: 50560
MHRA reference: 2019/009/012/228/019
Boston Scientific: iLab™ Polaris Multi-Modality Guidance System
18 September 2019
Ultrasound, imaging
Model: H749009710
MHRA reference: 2019/009/018/487/019
Cordis: Cordis® POWERFLEX® PRO PTA Dilatation Catheter
23 August 2019
Vascular cannula and catheters
MHRA reference: 2019/008/028/291/001
Edwards Lifesciences: EV1000A / EV1000N
FCA-128
Monitors, patient
MHRA reference: 2019/004/024/701/009
Johnson & Johnson: 1-DAY ACUVUE® MOIST®for ASTIGMATISM Contact Lenses
September 2019
Contact lenses & shells
MHRA reference: 2019/009/011/701/011
Maquet (Getinge):
11 September 2019
Infusion & transfusion, heart lung circuits 701067941, 701067942, 701067948, 701067949, 701067951, MHRA reference: 2019/009/012/228/006
Medtronic: Adapta™, Versa™, Sensia™, Relia™, Attesta™, Sphera™, and Vitatron™ 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: 2019/001/018/291/003
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: 2019/009/011/487/011
Ortho-Clinical: VITROS Chemistry Products CL- & K+ Slides
September 2019
IVDs, clinical chemistry
MHRA reference: 2019/009/017/601/001
World of Medicine: Aquilex Fluid Control System
17 August 2019
Infusion systems
Model: AQL-100CBS
MHRA reference: 2019/009/013/487/001