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
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Aesculap 鈥� B Braun: AESCULAP AEOS
19 October 2020
Surgical equipment, miscellaneous
Model: PV010
MHRA reference:
Bien Air: Foot Pedals
14 September 2020
Surgical power tools
MHRA reference:
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:
Covidien - Medtronic: Puritan Bennett 980 Ventilator System
October 2020
Lung ventilators
MHRA reference:
Dentsply Sirona: Drill Extension
29 July 2020
Surgical power tools
MHRA reference:
GE: Revolution Apex - Revolution CT with Apex edition
FMI 25493
Computed tomography
MHRA reference:
Karl Storz: Plastic container for sterilizing
22 October 2020
Cssd wash/clean/drying equipment
MHRA reference:
Kingstar Industries (GSM): Robotic Sponge
29 October 2020
Basic dressings, absorbents, swabs, procedure packs
Model: 20062
MHRA reference:
Laerdal Medical: Laerdal Compact Suction Unit (LCSU4)
20 October 2020
Airway suction equipment
Model: LCSU 4, 800 ml Complete unit
MHRA reference:
LivaNova: VNS 皇冠体育apprapy庐 SenTiva Duo庐 Generator
29 October 2020
Implantable neuro stimulators
Model: Model 1000-D
MHRA reference:
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:
Roche Diagnostics: ALB2, BILT3
October 2020
IVDs, clinical chemistry
MHRA reference:
Rocket Medical: Rocket KCH Foetal Bladder Drain
10 October 2020
Urinary catheters and accessories
MHRA reference:
Stryker: ZYPHR PERFORATOR BIT
23 October 2020
Surgical instruments, non-articulated cutting
MHRA reference:
Teleflex: Rusch TracFlex Plus Set, cuffed, TracFlex Plus PDT Set, Ruschcare TracFlex Plus Set, Cuffed
28 May 2020
Airway devices
MHRA reference:
皇冠体育apprmo Fisher Scientific: 皇冠体育apprmo Scientific
10 October 2020
IVDs, bacteriology
Model: PO1186A
MHRA reference:
Vectura Group: Breelib (Update to ref: FSN 13 鈥� 17 January 2020 )
28 October 2020
Nebulizers
Model: 08CD1042, 08CD1050, 08CD1051, 08CD1046
MHRA reference: