Field Safety Notices: 7 to 10 May 2019
List of field safety notices (FSNs) from medical device manufacturers from 7 to 10 May 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
Abbott: ARCHITECT c4000 / c8000 / c16000 Mixer
01 May 2019
IVDs, clinical chemistry
MHRA reference:
Biomet (Zimmer): Femoral Drill Guide
8 May 2019
Orthopaedic surgical instruments - measuring tools femoral drill guide
MHRA reference:
Beckman: Access Free T4' Access Free T3, Access Total T3, Access Thyroglobulin, Access GI Monitor, Access Thyroglobulin Antibody II
03 May 2019
IVDs, clinical chemistry
MHRA reference:
CardinalHealth: Monoject鈩� needles and cannulas
01 May 2019
Injection devices
MHRA reference:
CardinalHealth - Medtronic: Mahurkar鈩� Triple Lumen Catheter; Mahurkar鈩� Dual Lumen Catheter; Argyle鈩� Single Lumen Catheter
May 2019
Vascular cannula and catheters
MHRA reference:
Carestream: Carestream Health
03 May 2019
Computed tomography
OnSight 3D Extremity System
MHRA reference:
Medical Service - Teleflex: Mobile SL, Ch 12, 40 cm, Ergothan/Mobile SL, Ch 14, 40 cm, Ergothan/ Mobile SL, Ch 14, 20 cm, Ergothan
09 May 2019
Urinary catheters and accessories
MHRA reference:
Omixon Biocomputing
07 May 2019
IVDs, immunology
MHRA reference:
Philips: Philips SureSigns VS Monitors
April 2019
Monitors, patient
MHRA reference:
QIAGEN: RNeasy DSP FFPE Kit
06 May 2019
IVD, genetic testing RNeasy DSP FFPE Kit
MHRA reference:
Randox: G-6-PDH Control Deficient and Normal
01 May 2019
IVDs, clinical chemistry
Model: PD2617, PD2618
MHRA reference:
Redcord: Redcord Axis
29 April 2019
Therapy, traction 110050
MHRA reference:
SenoRx: EnCor庐 Breast Biopsy Probe
01 May 2019
Mammography
Model: ECP0110G, ECP017G, ECP0110GV, ECP017GV, ECP0112G, ECP0112GV
MHRA reference:
Strathclyde Pharmaceuticals- Munro Group: Brand
07 May 2019
IVDs, self / home testing
Accu-Chek Active test strips
MHRA reference:
Terumo: SOLOPATH庐 Expandable, SOLOPATH庐 Re-collapsible
May 2019
Vascular cannula/catheter accessories
MHRA reference:
Una Health: VTRUST TD-4258
18 January 2019
IVDs, self / home testing
Model: TD-4258
MHRA reference: