Field Safety Notices: 5 to 9 July 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 5 to 9 July 2021.
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
Accora: Configura Advance
21 June 2021
Pressure relief cushions
Model: CHAIR-0-SC1-030, CHAIR-0-SC2-030, CHAIR-0-SC3-050, CHAIR-0-SC4-050
MHRA reference: 2021/007/002/601/002
Baxter: EASYGRIP FLO-41 Precision MIS Delivery System
28 June 2021
Haemostatic agents
MHRA reference: 2021/006/024/291/001
BD: HIGHFLEX Basket
06 July 2021
Surgical instruments, minimal access
MHRA reference: 2021/006/030/291/005
Bolton Surgical: Portmann Needle Straight
210503-21-005
Injection devices
MHRA reference: 2021/006/009/601/501
Ceram Ptee: FiLaC Fistula Kit, LHP & HeLP Procedure Kit
26 April 2021
Therapy, lasers
MHRA reference: 2021/007/006/487/001
Contura: Bulkamid Urethral Bulking System
11 June 2021
Implants, non-active, implantable incontinence and prolapse devices
MHRA reference: 2021/006/002/487/025
Cooper Surgical: Oxygen (O2) Sensors
04 June 2021
Lung ventilators
MHRA reference: 2021/005/024/601/004
GE Healthcare: OEC Elite - OEC 3D
06 July 2021
X Ray, fluoroscopy systems
MHRA reference: 2021/007/007/487/007
Herida Healthcare: PUREAIR120 Bariatric Mattress System Control Unit
01 July 2021
Mattresses - active/passive and overlays
Model: QF-32
MHRA reference: 2021/007/006/487/002
New Valve Technology: ALLEGRA Delivery System
25 June 2021
Implants, non-active, cardiovascular heart valves
Model: DSL-AO18G1RE1150
MHRA reference: 2021/006/023/601/501
Nouvag: MD11/MD30
11 August 2020
Dental appliances / instruments
Model: REF 3335/3330
MHRA reference: 2021/007/001/601/006
Pall: NANODYNE ELD Filter & LIPIPOR TNA Filter
02 July 2021
Infusion & transfusion, administration sets
Model: ELD96LLCE & TNA1E
MHRA reference: 2021/007/002/701/083
ReWalk Robotics: Persona
29 April 2021
Therapy, Standing & Walking
Model: Personal 6.0
MHRA reference: 2021/003/026/487/009
Siemens Healthineers: Artis zee / Q / Q.zen systems with SW VD12
June 2021
X Ray, fluoroscopy systems
MHRA reference: 2021/007/002/601/003
Binding Site: Freelite Human Kappa Free Kit for use on the Roche cobas systems
19 May 2021
IVDs, clinical chemistry
MHRA reference: 2021/005/026/601/501
Tytek Medical: PneumoDart
June 2021
Surgical instruments, minimal access
Model: TM 317
MHRA reference: 2021/007/004/701/002