Field Safety Notices: 13 to 17 December 2021
List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 December 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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FSNs before this date are on the
Acutronic: Fabian HFO, +nCPAP Evolution, Therapy Evolution (Update to FSN 26 to 30 July 2021)
30 November 2021
Lung ventilators
Model: 111001, 111001.01, 112001, 113001, 122001, 122012, 121001, 121012
MHRA reference:
Avanos: MIC & MIC-KEY Enteral Feeding Tube Kit, CORFLO NG/NI TUBES, Initial Placement Kits (Avanos
Introducer Kit, MIC & CORFLO PEG and PEJ), ON-Q Systems (Pumps & Catheters, with Luer Lock & NRFit), ON-Q* Expansion Kits: Catheters with Luer Lock & NRFit (Soaker, SilverSoaker)
25 October 2021
Feeding systems and tubes
MHRA reference:
Avanos: Multi-Access Port Closed Suction System for Adults
30 November 2021
Airway suction equipment
MHRA reference:
Cepheid: Xpert Ebola
29 November 2021
IVDs, bacteriology
MHRA reference:
Helena Biosciences: V8
December 2021
IVDs, clinical chemistry
MHRA reference:
Skinvella: Deep, SubQ, Fine
20 September 2021
Implants, reconstructive, body contouring
MHRA reference:
Vigmed: CLiP Ported
30 November 2021
Vascular cannula and catheters
Model: VP183211
MHRA reference: