Field Safety Notices: 15 to 19 March 2021
List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 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.
Latest FSNs
View the 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
Abbott: Assurity, Endurity
15 March 2021
Implants, active, pacemakers
Model: PM1152, PM1160, PM1172, PM1240, PM1272, PM2152,
PM2160, PM2172, PM2240, PM2260, PM2272
MHRA reference: 2021/003/016/487/016
Biosense Webster: CARTO Vizigo Bi-Directional Guiding Sheath
February 2021
Vascular cannula and catheters
MHRA reference: 2021/003/016/487/020
Boston Scientific: MAMBA 135 and MAMBA Flex 135 Microcatheters
March 2021
Vascular cannula and catheters
MHRA reference: 2021/003/016/487/021
GAMA Healthcare: Clinell Universal Wipes
22 January 2021
Disinfectants for medical devices
MHRA reference: 2021/003/012/601/013
GE Healthcare: MAC 2000
16 March 2021
Electrophysiology measurement
MHRA reference: 2020/012/014/401/010
B.Braun: HISTOACRYL Transparent / LAPFIX / PROSET OFX
15 March 2021
Adhesive control devices
Model: 1050060, 1050071
MHRA reference:2021/003/009/601/001
This Field Safety Notice (FSN) is an update to FSN dated 8 March 2021 and has subsequently been updated on 27 April 2021. These FSNs include different models and batch numbers.
Please note the FSN dated 15 March originally contained a typographical error referring to an FSN of 3 March. This has been amended by the manufacturer and now correctly refers to the FSN dated 8th March.
ICU Medical: Spiros
12 March 2021
Infusion & transfusion, administration sets
Model: 011-CH3967; CH3235
MHRA reference: 2021/003/012/701/025
James Leckey Design: MyWay
01 March 2021
Walking aids, rollators
Model: 173-1600, 173-2600, 173-3600
MHRA reference: 2021/003/015/601/004
Leica Biosystems: BOND Detection (various), BOND Instruments
11 March 2021
IVDs, cytopathology & histopathology
Model: DS9800, DS9390, TA9145, BOND-III, BOND-MAX.
MHRA reference: 2021/003/012/601/009
Medtronic: Signia Small Diameter Curved Tip Intelligent Reload
March 2021/FA965
Staples and staple guns
Model: SIGSDS30CTV, SIGSDS30CTVT, SIGSDL45CTVT
MHRA reference: 2021/003/012/487/007
Medtronic: MiniMed 780G Insulin Pump; MiniMed 670G Insulin Pump (only models used in Clinical Studies*)
March 2021/FA963
Infusion systems
Model: ump 780G models: MMT-1885, MMT-1886;
Kit 780G models: MMT-1895; MMT-1896;
Pump models Clinical Studies:
MMT-1740; MMT-1741; MMT-1742
MHRA reference: 2021/003/016/291/001
Medtronic: Activa Clinician Programmer Application
March 2021/FA968
Implantable neuro stimulators
Model: A610
MHRA reference: 2021/003/017/487/001
Medtronic: Activa Clinician Programmer Application
March 2021/FA969
Implantable neuro stimulators
Model: A610
MHRA reference: 2021/003/017/487/002
Nissha Medical Technologies: Vermed
15 March 2021
Endoscopes, flexible
MHRA reference: 2021/003/016/487/022
Siemens Healthcare: ADVIA Chemistry System
March 2021/CHI21-01.A.OUS
IVDs, clinical chemistry
MHRA reference: 2021/003/015/601/001
Siemens Healthcare: ADVIA 2120/2120i Hematology System
March 2021/ HSW21-01.A.OUS
IVDs, haematology
Model: See FSN
MHRA reference: 2021/003/015/601/003
Stryker: Pediatric Restraint System (Removable)-XPS Mattres
March 2021
Mattresses - active/passive and overlays
MHRA reference: 2021/003/005/291/009