Field Safety Notices: 3 to 7 May 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 3 to 7 May 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
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View . FSNs before this date are on the
Acutronic: fabian HFO, +nCPAP evolution and therapy evolution
23 April 2021
Lung ventilators
Model: 111001, 111001.01, 112001, 113001, 122001, 121001 121012, 7050.IB, 122001, 7250.IB/122011, 122012
MHRA reference:
Arthrex: Angel cPRP Processing Set (EU)
R526
Centrifuges
Model: ABS-10064
MHRA reference:
Bausch + Lomb: Biotrue, ReNu, EasySept, Sensitive Eyes and Boston contact lens solutions
04 May 2021
Contact lenses, care products
Model: Biotrue, ReNu, EasySept, Sensitive Eyes and Boston contact lens solutions
MHRA reference:
BD: Groshong catheters
03 May 2021/MDS-21-4027
Vascular cannula and catheters
MHRA reference:
BD: Venflon Pro Safety I.V. Cannula
04 May 2021/MDS-20-3801
Vascular cannula and catheters
MHRA reference:
GTA: Various
23 April 2021
Surgical instruments, minimal access
MHRA reference:
Lima Corporate: Multigen Plus H knee system
07 May 2021
Joint prosthesis, knee
Model: all Multigen Plus H components
MHRA reference:
Medtronic: HVAD Pump (This is an update to FSN wk 21-24 December 2020)
May 2021/FA944
Implantable ventricular assist devices
Model: 1104
MHRA reference:
Sentinel Diagnostics: ACE Control Set
29 April 2021
IVDs, clinical chemistry
MHRA reference:
Soluscope: Serie 4 PA
30 April 2021
Cssd wash/clean/drying equipment
Model: SL-V4-PA
MHRA reference:
Teleflex: RUSCHELIT Super Safety Clear Tracheal Tube
30 April 2021
Airway devices
MHRA reference: