Field Safety Notices - 6 March - 10 March 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 6 - 10 March 2017
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
Aesculap: MINOP INVENT 30DG TROCAR D8.3MM L150MM
06 March 2017
Surgical instruments, minimal access
Model: FH620R
MHRA reference:
B Braun: PROSET INFUSOMAT SPACE LINE PUR/0, 2碌m
06 March 2017
Infusion and transfusion, administration sets
Model: 8251284SP
MHRA reference:
Becton Dickinson: BD Vacutainer庐 SST鈩� II Advance Plus
24 February 2017
IVDs, specimen receptacles
MHRA reference:
Gambro: Prismaflex System, Prismaflex 4.11, Prismaflex 5.00 Row, Prismaflex 6.10 Row, Prismaflex 7.XX Row, Prismaflex 8.XX Row, Prismaflex
13 March 2017
Dialysis, haemofilters
Model: 107493,113082, 113874, 114489, 114870, 955052, 6023014700
MHRA reference:
HOYA: PENTAX Flexible video duodenoscope, PENTAX Flexible fiber duodenoscope
FSCA-PMJ-17-01-1
Endoscopes, flexible
Model: ED-3490TK, ED-3270K, ED-3430, ED-3430TK, ED-3670TK, FD-34V2
MHRA reference:
Menicon: Menicon soft 72
13 February 2017
Contact lenses & shells
MHRA reference:
Physio-Control: LIFEPAK 1000 AEDs
March 2017
Defibrillators, non-implantable
MHRA reference:
Samsung: Mobile Digital X-ray GM60A
FSCA_GM60A_160728006
X ray, mobiles
Model: GM60A
MHRA reference:
Siemens: Ammonia Flex reagent cartridge
07 March 2017
IVDs, clinical chemistry Model: Dimension Integrated Chemistry System
MHRA reference:
Siemens: Dimension Vista庐 Systems
March 2017
IVDs, clinical chemistry
MHRA reference:
Siemens: ADVIA Centaur BR Assay
March 2017
IVDs, clinical chemistry
MHRA reference:
Sysmex: Automated Hematology Analyzer XN-L series XN-550
06 March 2017
IVDs, haematology
Model: XN-550
MHRA reference:
Trinity Biotech: Premier Buffer A Reagent, Premier Buffer B Reagent
23 February 2017
IVDs, clinical chemistry
MHRA reference: