Field Safety Notices - 27 June - 1 July 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 27 June - 1 July 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
Allurion Technologies: Elipse Device
29 June 2016
Implants, non-active, gastrointestinal
Model: REF 10 and REF 10A
MHRA reference: 2016/006/030/291/019
B. Braun: Dialog, Dialog Advanced, Dialog+
23 June 2016
Dialysis, haemodialysis
Model: please see annex 1
MHRA reference: 2016/003/021/292/001
Biofrontera Pharma: BF-RhodoLED
29 June 2016
Therapy, adult phototherapy
MHRA reference: 2016/006/015/071/004
Biomet: Hard Tissue Replacement Polymer Implants
13 June 2016
Implant materials, bone substitutes
MHRA reference: 2016/006/023/291/014
Biosynex: Biosynex Exacto Pro test HIV - HIV16010004
8 June 2016
IVDs, viral microbiology
MHRA reference: 2016/006/010/299/021
ConMed Corporation: Core Suction Irrigation Handpieces
05 July 2016
Surgical equipment, miscellaneous
MHRA reference: 2016/006/024/701/005
Delcath Systems:CHEMOSAT Hepatic Delivery System
2 May 2016
Vascular cannula and catheters
Model: 400021, 400002
MHRA reference: 2016/006/015/601/013
Ivoclar Vivaden: OptraPol Small Flame / OptraPol Cup Refill
June 2016
Dental appliances / instruments
MHRA reference: 2016/006/022/071/004
Lifetech Scientific: CeraFlex™ Atrial Septal Defect (ASD) Occlude
14 March 2016
Implants, non-active, cardiac appendage and septal defect occluders / plugs
Model: L T-ASDf-OS/08/ .. /30/32
MHRA reference: 2016/003/004/292/003
Medtronic Xomed Inc.:NIM® Standard Reinforced EMG Endotracheal Tube, NIM Contact® Reinforced EMG Endotracheal Tube
29 June 2016
Airway devices
MHRA reference: 2016/006/030/291/002
Medtronic: 1x4 DBS Restore Adaptor and 2x4 DBS Restore Adaptor
23 June 2016
Implants, active, stimulators, neuro
Model: 64001, 64002
MHRA reference: 2016/006/023/291/002
MicroVention: PHIL (Precipitating Embolic Injectable liquid) Non-Adhesive Liquid Embolic System
FCA#2016-01
Implants, non-active, embolisation products
Model: LEN10250, LEN10300, LEN10350
MHRA reference: 2016/006/027/291/012
Miele & Cie: Olympus ETD 4
June 2016
Cssd wash/clean/drying equipment
MHRA reference: 2016/006/022/701/009
Siemens: ADVIA Chemistry Theophylline Reagent (THEO_2)
June 2016
IVDs, clinical chemistry
MHRA reference: 2016/006/024/601/003
Siemens: Stratus CS Acute Care Diagnostics System
June 2016
IVDs, clinical chemistry
MHRA reference: 2016/006/027/601/003
Smith & Nephew: GENESIS Trocar Pins
28 June 2016
Orthopaedic surgical instruments - measuring tool
MHRA reference: 2016/006/028/701/009
Smith & Nephew: Twinfix Quick-T Knot Pusher Suture Cutters
21 June 2016
Surgical Instruments, manipulating
MHRA reference: 2016/006/016/701/022
Sorin: Heating unit, pad, water, system
21 June 2016
Blood/fluid warming systems
Model: 16-02-50, 16-02-80, 16-02-81, 6-02-82, 16-02-85, 16-02-95, 16‑70‑00 ‑ HeaterCooler & FlexTherm
MHRA reference: 2016/006/023/291/003
Technical Service Consultants: Probact Transport Swab
27 April 2016
IVDs, specimen receptacles
Model: TS/5-17
MHRA reference: 2016/006/027/291/001
Stryker: AutoPlex® System
27 June 2016
Bone cement and tools
Model: 0605-887-000
MHRA reference: 2016/006/023/291/006
Thermofisher Scientific: Oxoid GC Agar
24 June 2016
IVDs, bacteriology
Model: CM0367
MHRA reference: 2016/006/028/601/004
Zimmer: Twist drill
27 June 2016
Surgical power tools
MHRA reference: 2016/006/027/291/018