Field Safety Notice: 21 October to 25 October
List of field safety notices (FSNs) from medical device manufacturers from 21 October to 25 October
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
Allergan: XEN Glaucoma Treatment System
30 October 2019
Implants, non active, intraocular
Model: XEN 45
MHRA reference: 2019/010/018/487/010
Berchtold (Stryker): Light Head Cover, Printed, F 528 / F628
15 April 2019
Lamps & lights
MHRA reference: 2019/004/010/291/004
Boston Scientific: Advanix™ Pancreatic Stent
21 October 2019
Implants, non active, non vascular stents
Model: M00536610 - Advanix Panc Stent 10Fr x 3cm
MHRA reference: 2019/010/022/487/002
Breas Medical (Nippy): All NIPPY + range ventilators
16 October 2019
Lung ventilators
MHRA reference: 2019/010/018/291/001
Diamed (Bio-Rad): IH-QC 1
17 October 2019
IVDs, haematology
MHRA reference: 2019/010/021/701/006
Edwards Life Sciences: EZ Glide Aortic Cannula
FCA146
Vascular cannula and catheters
Model: EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA
MHRA reference: 2019/010/023/291/013
Eurovema: Euroflex work chairs with Forma chassi
6.6.2-2019-47648
Chairs
Model: 80XXXXXX, 241-XX, 242-XX, 291-XX, 292-XX,841-XX, 891-XX
MHRA reference: 2019/010/023/291/002
HERDEGEN: ADVANCE
21 October
Walking aids, crutches
Model: 2009** + 2059**
MHRA reference: 2019/010/023/291/001
INNOTERE GmbH: INNOTERE Paste-CPC, 3ml
09 September 2019
Bone cement and tools
Model: 111VX2
MHRA reference: 2019/010/017/701/020
Roche: Accu-Chek® Guide blood glucose meter
SB_RDC_2019_03
IVDs, self / home testing
MHRA reference: 2019/010/021/701/009
Siemens Healthcare Diagnostics: Atellica IM Active-B12 (Holotranscobalamin) (AB12)
October 2019
IVDs, clinical chemistry
MHRA reference: 2019/010/017/601/005
Tandem Diabetes Care: t: slim X2 Insulin Pump
16 October 2019
Infusion systems
MHRA reference: 2019/010/010/701/037
Teleflex Medical: Auto Endo5 ML
14 October 2019
Clip appliers
MHRA reference: 2019/010/014/701/055