Field Safety Notice - 11 to 15 June 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 June 2018.
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 (St Jude Medical Inc.): CardioMems Hospital and Patient Electronic System
14 June 2018
Implants, active, monitors and recorders
Model: CM3000, CM1100
MHRA reference: 2018/006/013/291/001
B Braun: SAFIL & NOVOSYN
7 June 2018
Sutures
MHRA reference:2018/006/008/601/003
Bard: Arctic Sun® Temperature Management System
FA2018-17
Heating, patient, electrical pads & blankets
MHRA reference: 2018/006/011/601/003
Becton Dickinson: BD Vacutainer® Urine Collection Cup
4 June 2018
IVDs, specimen receptacles
MHRA reference: 2018/005/023/291/008
Becton Dickinson: BD FACS™ Universal Loader
8 June 2018
IVDs, haematology
MHRA reference: 2018/006/013/291/016
BioFire Diagnostics: FilmArray Blood Culture Identification (BCID) Pan
June 2018
IVDs, bacteriology
MHRA reference: 2018/003/026/701/019
Cardinal Health: Hydroline Trumpet Valve
11 June 2018
Surgical equipment, miscellaneous
MHRA reference: 2018/006/011/601/014
Dialab: CK-MB, opt. DGKC / IFCC; GLDH, DGKC
7 June 2018
IVDs, clinical chemistry
MHRA reference: 2018/006/014/701/007
Grifols: MDmulticard® Basic Extended Phenotype
13 June 2018
IVDs, blood transfusion
MHRA reference: 2018/006/013/701008
Guangzhou Sunray Medical Apparatus: SRF618X9 B Maternal and Fetal Monitor
13 April 2018
Monitors, foetal
MHRA reference: 2018/006/011/291/009
Medtronic: Single Chamber Temporary Pacemaker
June 2018
Pacemakers, external
Model: 53401
MHRA reference: 2018/006/011/291/019
Ortho-Clinical: VITROS Chemistry Products Na+ Slides
June 2018
IVDs, clinical chemistry
MHRA reference: 2018/006/011/601/007
Randox Laboratories: Liquid Assayed Specific Protein Controls
03 May 2018
IVDs, clinical chemistry
Model: PS2682, PS2683, PS2684
MHRA reference: 2018/005/008/601/005
Randox: Liquid Cardiac Control
05 June 2018
IVDs, clinical chemistry
Model: CQ5053
MHRA reference: 2018/006/008/601/009
RaySearch Laboratories: RayStation
5 June 2018
Radiotherapy planning and verification systems
Model: RayStation 2.5, RayStation 3.5, RayStation 4.0, RayStation 4.3, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2) and RayStation 7 (RayPlan 7)
MHRA reference: 2018/006/011/701/006
Sirona Dental Systems (Dentsply): CEREC AC Connect
15 April 2018
Intense pulse light Source
MHRA reference: 2018/006/011/478/003
Terumo: Terumo® Hypodermic NEOLUS Needle
June 2018
Injection devices
Model: NN-2516R04T, NN-2525R, NN-2116R, NN-2125R, NN-2316R, NN-2325R04T, NN-2516R
MHRA reference: 2018/006/012/081/003
Thermo Fisher Scientific: Oxoid
19 May 2018
IVDs, bacteriology
Model: CT0159B
MHRA reference: 2018/004/024/601/004