Field Safety Notice: 19 to 23 August 2019
List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 August 2019.
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
Armstrong Medical
16 August 2019
Breathing system components
Model: 15mmØ Collapsible/Extendible Tubing - present in Armstrong Medical Catheter Mounts, Face Mask Kits and some Breathing Circuits
MHRA reference: 2019/008/016/487/007
B Braun: C0027407, C0026248; G0994318, G0994725; C0024533
09 August 2019
Sutures
MHRA reference: 2019/008/009/228/002
Boston Scientific: EMBLEM™ S-ICD and EMBLEM™ MRI S-ICD
August 2019
Implants, active, defibrillators
Model A209 - A2019
MHRA reference: 2019/008/021/487/028
Cantel Medical UK: Hook-up for Cantel EWDs
19 August 2019
Cssd wash/clean/drying equipment
MHRA reference: 2019/008/016/487/008
CME McKinley: T34 TM Ambulatory Syringe Pump
July 2019
Infusion systems
MHRA reference: 2019/008/019/487/023
DiaMed GmbH: IH-1000
21 August 2019
IVDs, blood transfusion
Model: 001000
MHRA reference: 2019/008/022/701/009
Flowonix Medical: Prometra Programmers (REF 91828)
12 August 2019
Implants, active, infusion pumps
Model: Prometra Programmers (REF 91828) (Software version 1.03, 1.06, 1.06.1)
MHRA reference: 2019/008/015/487/005
Intersurgical: swivel elbows
25 July 2019
Breathing System Components
MHRA reference: 2019/007/019/291/001
Philips: Efficia DFM 100
August 2019
Defibrillators, non-implantable
Model: 866199
MHRA reference: 2019/008/015/487/030
Roche - EFSN cobas: AssayTip/AssayCup tray
06 August 2019
IVDs, clinical chemistry
MHRA reference: 2019/008/009/487/008
Roche: STFR.
August 2019
IVDs, clinical chemistry
MHRA reference: 2019/008/016/701/008
Siemens: Atellica IM anti-CCP IgG (aCCP) assay Atellica IM Pregnancy-Associated Plasma Protein-A assay
August 2019
IVDs, immunology
MHRA reference: 2019/008/019/601/008
Siemens - ASI 19-04: Atellica CH 930 Analyzer
August 2019
IVDs, clinical chemistry
MHRA reference: 2019/008/020/601/006
Siemens: Atellica IM 1300 and IM 1600 Analyzers
August 2019
IVDs, clinical chemistry
MHRA reference: 2019/008/020/601/010
Spierings Orthopaedics: REX Cement Stop TM
22 August 2019
Joint prosthesis, hip
REX Cement Stop ø9, REX Cement Stop ø10, REX Cement Stop ø11.5, REX Cement Stop ø13.5, REX Cement Stop ø16
MHRA reference: 2019/008/022/701/008
St. Jude Medical
22 August 2019
CentriMag motor, OUS
201-10002
MHRA reference: 2019/008/022/291/004
Stryker: MESA 2 Deformity Polyaxial Screw; Size Ø6.5x45 mm
05 August 2019
Osteosynthesis, bone screws
MHRA reference: 2019/008/012/701/010
Stryker: Triathlon
14 August 2019
Joint prosthesis, knee
MHRA reference: 2019/008/012/701/006
Surgical Specialties - Altomed: UltraPlug
13 August 2019
Implants, non-active, intraocular
Model: A10212 (Manufacturer code PPLUG6)
MHRA reference: 2019/008/015/601/003
The Binding Site: Optilite C-Reactive Protein Reagent
20 August 2019
IVDs, clinical chemistry
NK044.OPT
MHRA reference: 2019/008/019/601/013
The Binding Site: VaccZyme™ Human Anti-Haemophilus Influenzae type b
21 August 2019
IVDs, immunology
MK016
MHRA reference: 2019/008/008/601/005
Vascular Solutions - Teleflex: TrapLiner Catheter
21 August 2019
Vascular cannula and catheters
MHRA reference: 2019/008/021/701/024
Zimmer: Sidus® Stem-Free Shoulder Humeral Head 50-18
19 August 2019
Joint prosthesis, shoulder
MHRA reference: 2019/008/019/291/013