Field Safety Notice: 26 to 30 October
List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 October 2020.
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
View a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Aesculap – B Braun: AESCULAP AEOS
19 October 2020
Surgical equipment, miscellaneous
Model: PV010
MHRA reference: 2020/010/023/291/002
Bien Air: Foot Pedals
14 September 2020
Surgical power tools
MHRA reference: 2020/009/014/487/002
Corvia Medical: InterAtrial Shunt Device (IASD) System II
FSCA-02-2020-09-28
Cardiac structural support or adaptation devices
Model: PN00261 IASD System II
MHRA reference: 2020/010/023/291/008
Covidien - Medtronic: Puritan Bennett 980 Ventilator System
October 2020
Lung ventilators
MHRA reference: 2020/010/026/291/008
Dentsply Sirona: Drill Extension
29 July 2020
Surgical power tools
MHRA reference: 2020/010/028/291/002
GE: Revolution Apex - Revolution CT with Apex edition
FMI 25493
Computed tomography
MHRA reference: 2020/010/023/291/005
Karl Storz: Plastic container for sterilizing
22 October 2020
Cssd wash/clean/drying equipment
MHRA reference: 2020/010/023/291/006
Kingstar Industries (GSM): Robotic Sponge
29 October 2020
Basic dressings, absorbents, swabs, procedure packs
Model: 20062
MHRA reference: 2020/010/029/291/022
Laerdal Medical: Laerdal Compact Suction Unit (LCSU4)
20 October 2020
Airway suction equipment
Model: LCSU 4, 800 ml Complete unit
MHRA reference: 2020/010/029/291/010
LivaNova: VNS Therapy® SenTiva Duo® Generator
29 October 2020
Implantable neuro stimulators
Model: Model 1000-D
MHRA reference: 2020/010/027/291/001
Medtronic: Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System
October 2020
Implants, non-active, cardiovascular heart valves
Model: EVOLUTR-23, EVOLUTR-26, EVOLUTR-29, EVOLUTR-34, EVOLUTPRO-23, EVOLUTPRO-26, EVOLUTPRO-29
MHRA reference: 2020/010/023/291/012
Roche Diagnostics: ALB2, BILT3
October 2020
IVDs, clinical chemistry
MHRA reference: 2019/008/028/701/001
Rocket Medical: Rocket KCH Foetal Bladder Drain
10 October 2020
Urinary catheters and accessories
MHRA reference: 2020/010/006/601/002
Stryker: ZYPHR PERFORATOR BIT
23 October 2020
Surgical instruments, non-articulated cutting
MHRA reference: 2020/010/023/291/003
Teleflex: Rusch TracFlex Plus Set, cuffed, TracFlex Plus PDT Set, Ruschcare TracFlex Plus Set, Cuffed
28 May 2020
Airway devices
MHRA reference: 2020/010/023/291/001
Thermo Fisher Scientific: Thermo Scientific
10 October 2020
IVDs, bacteriology
Model: PO1186A
MHRA reference: 2020/010/027/601/007
Vectura Group: Breelib (Update to ref: FSN 13 – 17 January 2020 )
28 October 2020
Nebulizers
Model: 08CD1042, 08CD1050, 08CD1051, 08CD1046
MHRA reference: 2020/001/015/601/001