Field Safety Notices: 14 to 18 December 2020
List of field safety notices (FSNs) from medical device manufacturers from 14 December to 18 December 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.
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Aacurat: pulla Strechlift ; / ArtikelNr. 8266001
11 November 2020
Moving & handling
MHRA reference:
Bausch & Lomb: 23GA Backflush/Extrusion Handpiece blunt
11 December 2020
Phacoemulsification / vitrectomy systems
Model: SUJ11, SUJ14
MHRA reference:
Baxter: VERITAS Collagen Matrix 12x25 cm
21 December 2020
Dermal substitues, tissue scaffods
MHRA reference:
Dexcom: Dexcom G6 sensor
December 2020
Continuous glucose monitoring systems (CGMS)
MHRA reference:
Illumina: VeriSeq NIPT Solution v2
15 December 2020
IVDs, clinical chemistry
MHRA reference:
Intersurgical: CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MA
17 December 2020
Nebulizers
MHRA reference:
Invacare: Action 3 Junior
12 October 2020
Wheelchairs, manual
MHRA reference:
Liko AB(Hillrom): Multirall 200
MOD1322
Moving & handling
Model: 3130001
MHRA reference:
Mathys: Affinis Inverse glenosphere
08 December 2020
Joint prosthesis, shoulder
Model: 60.30.3036
MHRA reference:
Medela Stryker: AXS Universal Aspiration Tubing
07612367052719
Surgical equipment, miscellaneous
Model: 077.0193
MHRA reference:
Medisafe(Steris): Distal Duck Kits (M20400) and Duck Bag Humidity Packs (M20350, M20358, M20359)
01 December 2020
Detergents
MHRA reference:
Medtronic: ARESTM Antibiotic-Impregnated Catheter
December 2020
Cerebrospinal fluid drainage, external
Model: 91101, 93092, 95001
MHRA reference:
Medtronic Delta: Delta Valve, Neonatal, Performance Level 1.0
Delta Valve, Neonatal, Performance Level 2.0 Delta Valve, Neonatal, Performance Level 1.5
December 2020
Implants, non active, hydrocephalus shunts
MHRA reference:
Radiometer: AQT90 FLEX analyzers
16 December 2020
IVDs, clinical chemistry
Model: 393-838
MHRA reference:
Spacelabs: SENTINEL
08 December 2020
Software as a medical device (SaMD)
Model: 98200 & 98201
MHRA reference:
Thermo Fisher Scientific: Remel
10 December 2020
IVDs, Bacteriology
Model: R21524
MHRA reference: