Field safety notices - 7 November - 11 November 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 7 November -11 November 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
Bausch + Lomb: EasySept Hydro Plus Peroxide Solution
28 October 2016
Contact lenses, care products
Model: EasySept Hydro Plus
MHRA reference: 2016/010/028/291/015
Compression Works: AAJT Abdominal Aortic Junctional Tourniquet
7 November 2016
Surgical equipment, tourniquets
Model: 63000
MHRA reference: 2016/011/007/601/005
Concert Medical: Galeo Pro Coronary Guide Wire
9 November 2016
Vascular cannula/catheter accessories
Model: Galeo Pro Coronary Guide Wire; 389781, 389782, 389783, 389784, 389785, 389786, 389787, 389788, 389791.
MHRA reference: 2016/011/008/601/020
Draeger: Infinity Acute Care System (M540)
October 2016
Monitors, patient
Model: MS25510, MS25520, MS26372
MHRA reference: 2016/011/008/291/003
EKF-diagnostic: Quo-Test HbA1c Analyzer
26 May 2016
Quo-Test HbA1c Analyzer
Model: 0108
MHRA reference: 2016/010/011/701/012
Exactech: Equinoxe Reverse Shoulder Defining Screw Kit
17 October 2016
Joint prosthesis, shoulder
Model: Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
MHRA reference: 2016/011/004/701/024
Gyrus ACMI: Port Seal and Y-Connector
1 November 2016
Endoscopes, flexible
Model: AUR-BP, UBP-Y
MHRA reference: 2016/011/004/601/011
Mako Surgical: Offset Cup Reamer Handle
17 October 2016
Surgical power tools
Model: Offset Cup Reamer Handle
MHRA reference: 2016/011/004/291/006
Mathys: balanSys UNI convex PE inlays x/5
8 November 2016
Joint prosthesis, knee
Model: 77.30.0211; 77.30.0221; 77.30.0231; 77.30.0241; 77.30.0251
MHRA reference: 2016/011/009/071/001
Maxilabs: Sodium Bicarbonate ear drops 10ml
9 November 2016
Substances for topical application (non-pharmaceutical)
Model: Ear wax softener
MHRA reference: 2016/011/008/291/001
MED-EL: SONNET Mini Battery Pack Cable
27 October 2016
Implants, active, hearing
MHRA reference: 2016/010/028/701/014
Radiometer Medical: PICO70
FAN 915-352
Storage and collection devices
MHRA reference: 2016/011/009/701/014
Siemens: IMMULITE 2000/IMMULITE 2000XPi PSA
4 November 2016
IVDs, clinical chemistry
Model: please see additional information
MHRA reference: 2016/011/003/601/014
Spiggle & Theis Medizintechnik: Inflation device
19 Feburary 2016
Vascular cannula and catheters
Model: 2080-9030020
MHRA reference: 2016/009/007/701/011
Teleflex:
7 November 2016
Surgical instruments, minimal access Model: ARROW® OnControl® Bone Lesion Biopsy System Tray, ARROW® OnControl® Aspiration System Tray, ARROW® OnControl® Bone Lesion Biopsy System Tray, ARROW® OnControl® Bone Lesion Biopsy System Trays
ARROW® OnControl® Bone Marrow Biopsy System Comprehensive Tray, ARROW® OnControl® Bone Marrow Biopsy System Tray, ARROW® OnControl® Ported Aspiration System Tray, ARROW® OnControl® System Sterile Procedure Tray, OnControl® Biopsy System Ported Needle Tray
MHRA reference: 2016/011/008/299/007