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庐 OnControl庐 Bone Lesion Biopsy System Tray, ARROW庐 OnControl庐 Aspiration System Tray, ARROW庐 OnControl庐 Bone Lesion Biopsy System Tray, ARROW庐 OnControl庐 Bone Lesion Biopsy System Trays
ARROW庐 OnControl庐 Bone Marrow Biopsy System Comprehensive Tray, ARROW庐 OnControl庐 Bone Marrow Biopsy System Tray, ARROW庐 OnControl庐 Ported Aspiration System Tray, ARROW庐 OnControl庐 System Sterile Procedure Tray, OnControl庐 Biopsy System Ported Needle Tray
MHRA reference: 2016/011/008/299/007