Field safety notices - 4 January to 8 January 2016
List of field safety notices (FSNs) from medical device manufacturers from 4 January to 8 January 2016.
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
Applied Medical Technology: TLC self-retaining retractor frame system
5 January 2016
Surgical instruments, minimal access
MHRA reference: 2016/001/005/292/018
Bard: Arctic Sun temperature management system
FA2015-30
Heating, patient, electrical pads & blankets
MHRA reference: 2015/011/012/601/016
B Braun: Certofix Quattro v 815
24 December 2015
Vascular cannula and catheters Model: Certofix Quattro
MHRA reference: 2015/012/021/291/022
Boston Scientific Corporation: Chariot guiding sheath
17 December 2015
Vascular cannula and catheters
MHRA reference: 2015/011/023/292/008
Caesarea Medical Electronics: T60 ambulatory syringe pump, TPCA PCA syringe pump
16 December 2015
Infusion systems
Model: 100-100PSLM, 100-106PSLMTPCA, PMP00007
MHRA reference: 2015/010/026/291/007
Caesarea Medical Electronics: T34 ambulatory syringe pump
12 October 2015
Infusion systems
Model: 100-100SM
MHRA reference: 2015/010/026/291/006
Cyberonics: VNS Therapy Aspire SR generator
15-005
Implants, active, stimulators, neuro
Model: 106
MHRA reference: 2015/011/024/292/021
Cytosorbent: Haemoperfusion system adsorption column
22 December 2015
Dialysis, haemofilters
Model: CytoSorb© 300mL Device
MHRA reference: 2015/012/029/292/003
Depuy Synthes: Extraction screw for PFNA blade
30 December 2015
Surgical instruments, implant
Model: 356.825
MHRA reference: 2016/001/004/291/002
Immucor Inc: LIFECODES HLA-DQA1/B1 typing kit
30 December 2015
IVDs, immunology
Model: 628930
MHRA reference: 2016/001/004/292/005
Medtronic: Specify 5-6-5 surgical lead and Specify 2x8 surgical lead
6 January 2016
Implants, active, leads, neuro
Model: 39565 and 39286
MHRA reference: 2016/001/005/292/010
Nutricia: Flocare infusion sets with ENFit transition adaptors
7 January 2016
Feeding systems and tubes
MHRA reference: 2015/012/010/302/001
Rayner Intraocular Lenses: C-flex Aspheric, Superflex Aspheric, Sulcoflex Aspheric, Sulcoflex Toric and T-flex Aspheric
1 January 2016
Implants, non-active, intraocular
Model: 970C, 920H, 653L, 653T, 573T and 623T
MHRA reference : 2016/001/001/601/001
Roche Diagnostics: cobas b 123
23 December 2015
IVDs, extra laboratory testing
Model: cobas b 123 fluid pack 200 (Cat. No. 05403308001) cobas b 123 fluid pack 400 (Cat. No. 05403154001) cobas b 123 fluid pack 700 (Cat. No. 05403286001) cobas b 123 fluid pack COOX 200 (Cat. No. 05169992001) cobas b 123 fluid pack COOX 400 (Cat. No. 05170036001) cobas b 123 fluid pack COOX 700 (Cat. No. 05170052001)
MHRA reference: 2016/001/007/292/002
Siemens Healthcare Diagnostics: ADVIA Centaur Systems PSA
4 January 2016
IVDs, clinical chemistry
MHRA reference: 2016/001/004/601/003
St. Jude Medical: All models of RF enabled St. Jude Medical Ellipse™, Fortify Assura™, Unify Assura™, and Quadra Assura™ implantable cardioverter defibrillators (ICDs) and Assurity™ and Allure™ pacemakers when used with Merlin@home™ RF Remote Monitoring Transmitter Model EX1150.
December 2015
Implants, active, pacemakers
MHRA reference: 2015/008/019/291/003