Field Safety Notice - 27 March to 31 March 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 27 - 31 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
View the latest FSNs
Abbott: IRIDICA Bead Beater (BB)
FA-AM-MAR2017-218 -29 March 2017 IVDs, bacteriology
MHRA reference: 2017/003/029/701/023
Abbott: HeartMate II ® System Controller
29 March 2017
Implantable ventricular assist devices Model: 105109
MHRA reference: 2017/003/030/701/007
Aesculap: Diamond burrs
27 March 2017
Surgical power tools MHRA reference: 2017/003/029/701/012
bioMérieux: ETEST® OX 256 (OXACILLIN)
29 March 2017
IVDs, bacteriology MHRA reference: 2017/003/029/299/023
Cook: See Product List attached
20 March 2017
Urinary catheters and accessories Model: Bush DL™ Ureteral Illuminating Catheter Set, Bush SL™ Ureteral Illuminating Catheter Set
MHRA reference: 2017/003/024/701/014
Cook: Check-Flo® Hemostatic Device with Blue Valve Recall Extension
17 March 2017
Vascular cannula and catheters MHRA reference: 2017/003/030/701/009
GE: Vivid E80 / E90 / E95 / S60N / S70N
FMI 76164 & 76168 Ultrasound, imaging MHRA reference: 2017/003/029/701/009
GE: Vivid S60 / S70
FMI 76168 Ultrasound, imaging MHRA reference: 2017/003/029/701/017
Intersurgical: F Solus, Flexible wire reinforced laryngeal mask, sizes 2, 3, 4 and 5
164826 Airway devices MHRA reference: 2017/003/028/299/021
Intuitive Surgical: EndoWrist Stapler Release Kit; Surgical Wrench
23 March 2017
Endoscopes, rigid Model: EndoWrist Stapler Release Kit MHRA reference: 2017/003/023/701/022
LeMaitre Vascular: Hydro LeMaitre® Valvulotome
13 February 2017
Surgical instruments, non-articulated cutting Model: 1009-00, 1009-00J
MHRA reference: 2016/008/009/701/012
Merit Medical: Medallion® syringe
Medallion 1mL syringe recall 2017 Injection devices MHRA reference: 2017/003/029/701/016
Orthos: Wheelchair
24 March 2016
Wheelchairs, manual Model: Drift / Impluse MHRA reference: 2017/001/011/410/001
Richard-Allan Scientific: Shandon Rapid Chrome Kwik-Diff (Kit)
UK RAS KD #17 IVDs, cytopathology & histopathology Model: Assay/ Reagent
MHRA reference: 2017/003/023/701/023
Servicio Integral Hospitalario: Custom Packs that contain LaserEdge® knives
28 March 2017
Surgical devices, non-powered
MHRA reference: 2017/003/020/291/024