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
View a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
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: 2021/004/030/487/005
Arthrex: Angel cPRP Processing Set (EU)
R526
Centrifuges
Model: ABS-10064
MHRA reference: 2021/005/003/701/006
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: 2021/005/004/487/014
BD: Groshong catheters
03 May 2021/MDS-21-4027
Vascular cannula and catheters
MHRA reference: 2021/004/030/291/001
BD: Venflon Pro Safety I.V. Cannula
04 May 2021/MDS-20-3801
Vascular cannula and catheters
MHRA reference: 2021/002/018/291/010
GTA: Various
23 April 2021
Surgical instruments, minimal access
MHRA reference: 2021/004/012/487/019
Lima Corporate: Multigen Plus H knee system
07 May 2021
Joint prosthesis, knee
Model: all Multigen Plus H components
MHRA reference: 2021/005/007/701/026
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: 2020/012/018/291/004
Sentinel Diagnostics: ACE Control Set
29 April 2021
IVDs, clinical chemistry
MHRA reference: 2021/005/004/487/002
Soluscope: Serie 4 PA
30 April 2021
Cssd wash/clean/drying equipment
Model: SL-V4-PA
MHRA reference: 2021/004/030/291/006
Teleflex: RUSCHELIT Super Safety Clear Tracheal Tube
30 April 2021
Airway devices
MHRA reference: 2021/005/004/487/001