Field Safety Notices: 1 to 5 March 2021
List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 March 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.
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ArjoHuntleigh: Minstrel
18 December 2020
Hoists and slings
Model: HMA0006, HMA0006-XX, HMA0007, HMA0007-XX
MHRA reference:
Baxter Healthcare: Sterile water for irrigation
26 February 2021
Surgical equipment
Model: Sterile water for irrigation, 1000 ml
MHRA reference:
Becton Dickinson: Bodyguard 121 Twins
03 March 2021
Infusion systems
Model: Bodyguard 121 Twins
MHRA reference:
BIOMERIEUX: VIDAS CMV IGM 30 TESTS - 30205
02 March 2021
IVDs, viral microbiology
Model: VIDAS CMV IGM 30 TESTS - 30205
MHRA reference:
Boston Scientific: 4G LATITUDE MIMIC Cell Adapter 6227
19 February 2021
Implants, active, general
Model: 4G LATITUDE MIMIC Cell Adapter 6227
MHRA reference:
Beaver Visitec International: CustomEyes Kits & Malosa Kits - Syringes and Needles
March 2021
Phacoemulsification / Vitrectomy systems
Model: BVI CustomEyes Kits and Malosa Kits 鈥� BD Syringes and Needles
MHRA reference:
Cardinal Health: Kangaroo Enteral Feeding Non-Sterile Pump Sets
March 2021
Feeding systems and tubes
Model: Kangaroo Enteral Feeding Non-Sterile Pump Sets
MHRA reference:
Depuy Synthes: MBT Cemented Keel Tibial Base ATTUNE FB AND RP
05 March 2021 / 1932449
Joint prosthesis, knee
Model: MBT Cemented keel tibial base Attune FB and RP
MHRA reference:
DePuy Synthes: Pinnacle Hip System
26 February 2021
Acetabular cup
Model: Pinnacle Hip System
MHRA reference:
DTR Medical: Tibbs Arterial Cannula Micro Olive
02 March 2021
Vascular Cannula And Catheters
Model: TAC20MO
MHRA reference:
Hologic: Panther Fusion Tube Tray
15 March 2021
IVDs, viral microbiology
Model: Panther Fusion Tube Tray FAB-15004
MHRA reference:
Mathys: Bettlach Affinis Inverse glenosphere
04 February 2021
Prosthesis shoulder
Model: 60.30.3036
MHRA reference
Medtronic: Bio-Console 560 Extracorporeal Blood Pumping Console
March 2021 / FA962
Infusion & transfusion, heart lung circuits
Model: 560BC, 560BCS, 560BC1, 560BCS1, R560BCS1
MHRA reference:
Medtronic: HeartWare Ventricular Assist System HVAD
March 2021 / FSN FA958
Implantable ventricular assist devices
Model: Controller 1401, 1403, 1407, 1420
Battery 1650DE
Controller AC Adapter 1425, 1430
Controller DC Adapter 1440
Alarm Adapter 1450
Data Cable 1575
MHRA reference:
Merit Medical: General/Plastic surgical procedure kit, non-medical
19 February 2021
Surgical devices, non-powered
Model: Merit Convenience Kits and Procedure Packs Containing BD Syringes and Needles
MHRA reference
Neuromedex: MEDILOOPS
25 February 2021
Surgical Instruments, minimal access, retractor
Model: 01.2801, 01.2802, 01.2804, 01.2811, 01.2812, 01.2814, 01.2821
MHRA reference:
Sol group: Penelope
10 December 2020
Lung ventilators
Model: Penelope
MHRA reference:
Siemens Healthcare: YSIO X.pree
09 February 2021
X Ray, general
Model: YSIO X.pree
MHRA reference:
Siemens Healthcare: Sensis, Sensis Vibe Combo, Sensis Vibe Hemo
March 2021
Electrophysiology measurement
Model: 10764561, 11007642, 11007641
MHRA reference:
Sysmex: Automated Blood Coagulation Analyzer CN-3000, CN-6000
March 2021
Coagulation
Model: Automated Blood Coagulation Analyzer CN-3000, CN-6000
MHRA reference:
Teleflex: SDN TracFlex Plus Tracheostomy Tube Set, CuffedTracFlex Plus PDT Set
01 March 2021
Tube Tracheostomy
Model: TracFlex Plus Tracheostomy Tube Set, Cuffed TracFlex Plus PDT Set
MHRA reference:
ThermoFisher: Applied Biosystems COVID-19 CE-IVD Int. SW
03 March 2021
IVDs, SARS-CoV-2 PCR test
Model: 100095578 (v1.3); 100095575 (v2.3)
MHRA reference: