Field Safety Notices: 29 August to 2 September 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 29 August to 2 September 2022.
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
B Braun: PERFUSOR LINE, PE, LL, 200 CM
27 July 2022
Infusion & Transfusion, Administration Sets
MHRA reference: 2022/007/028/601/502
Exactech: Knee and Ankle UHMWPE
01 August 2022
Joint Prosthesis, Knee
MHRA reference: 2022/008/026/596/011
GE Healthcare: Avance CS2, Avance CS2 Pro, Aisys CS2
Ref 34128
Anaesthetic Machines & Monitors
MHRA reference: 2022/008/026/701/026
IM Med: iM Duo B
20 June 2022
Disinfectants For Medical Devices
MHRA reference: 2022/006/023/601/001
IOLUTION: Softec HD Click
04 July 2022
Intraocular Lenses and Accessories
Model: 200-12-203-0020401
MHRA reference: 2022/008/031/601/507
Leica Microsystems: ARveo 8, ARveo, M530 OHX, PROvido
25 August 2022
Surgical Equipment, Miscellaneous
MHRA reference: 2022/008/026/596/003
Löwenstein Medical Technology: LM150TD
15 August 2022
Lung Ventilators
MHRA reference: 2022/008/026/596/005
Medtronic: Puritan Bennett 520 Ventilator, Puritan Bennett 560 Ventilator
August 2022
Lung Ventilators
Model: All
MHRA reference: 2022/009/001/291/022
Medtronic: Prevail Paclitaxel-coated PTCA Balloon Catheter
Ref FA1277
Vascular Cannula And Catheters
Model: PRV020010RX, PRV020015RX, PRV020020RX, PRV020025RX, PRV020030RX, PRV022510RX, PRV022515RX, PRV022520RX, PRV022525RX, PRV025010RX, PRV025015RX, PRV025020RX, PRV025025RX, PRV025030RX, PRV027510RX, PRV027515RX, PRV027520RX, PRV027525RX, PRV030010RX, PRV030015RX, PRV030020RX, PRV030025RX, PRV030030RX, PRV035010RX, PRV035015RX, PRV035020RX, PRV035025RX, PRV035030RX, PRV040010RX, PRV040015RX, PRV040020RX, PRV040025RX, PRV040030RX
MHRA reference: 2022/009/001/291/023
MELAG: Careclave 618
18 August 2022
Sterilizers, Steam (Autoclaves)
MHRA reference: 2022/008/026/596/006
Nutricia: Flocare Infinity enteral feeding pump
01 August 2022
Feeding Systems And Tubes
MHRA reference: 2022/008/015/596/002
PAJUNK: EpiLong NRFit 16G x 80mm
26 August 2022
Injection Devices
MHRA reference: 2022/008/022/601/001
Teleflex Medical: Iso-Gard Filter S with Expandi-Flex/Elbow, Tethered Cap; Iso-Gard Filter S; Iso-Gard Filter S with Expandi-FlexIso-Gard Filter S, Tethered Cap; Iso-Gard Filter S with Expandi-Flex, Tethered Cap; Filter + Catheter Mount
August 2022
Breathing System Components
MHRA reference: 2022/009/002/291/002
ZOLL: X Series and Propaq MD
26 August 2022
Defibrillators, Non Implantable
MHRA reference: 2022/009/001/291/003