Field Safety Notice - 12 November to 16 November
List of field safety notices (FSNs) from medical device manufacturers from 12 November to 16 November
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
CIVCO Medical Instruments: L25 Needle Guide Bracket
30 October 2018
Surgical instruments, minimal access
MHRA reference: 2018/011/012/291/005
Canon Medical Systems Corporation: Radrex-i
EU-8811
X ray, general
Model: DRAD-3000E/W8
MHRA reference: 2018/011/001/487/018
Cardinal Health: Protexis Neoprene Surgical Glove
31 October 2018
Gloves, surgical & examination
MHRA reference: 2018/011/014/701/012
Carestream Health: KODAK DirectView DR 7500 System
31 October 2018
X ray, general
MHRA reference: 2018/011/013/701/004
Exactech: Shoulder GPS Reverse Drill Kit; GPS Hex Pins
06 November 2018
Joint prosthesis, shoulder
MHRA reference: 2018/011/013/701/003
Fast Track Diagnostics: FTlyo2+.1; FTlyo2P.3; FTlyo48.1; FTlyo56.1
November 2018
IVDs, bacteriology
MHRA reference: 2018/011/009/701/011
Olympus: QIL 151-006
16 November 2018
Endoscopes, flexible
Model: Various
MHRA reference: 2018/011/015/291/002
Oscor: TB Series - Bipolar Pacing Leads
1035166-09/07/2018-01-R MDSS ref: MDD18.249
Implants, active, pacing leads, temporary
Model: Unshrouded Version Only
MHRA reference: 2018/011/014/701/014
Pennine: Prestrol Suction Catheter – FG/CH 7 (2.3mm), 48cm
14 November 2018
Suction system catheter general-purpose
MHRA reference: 2018/011/013/291/002
Randox: Liquid Protein Calibrators
12 November 2018
IVDs, clinical chemistry
Model: IT2692
MHRA reference: 2018/011/006/601/001
Randox Laboratories: Evidence Investigator
12 November 2018
IVDs, clinical chemistry
MHRA reference: 2018/011/012/601/003
RaySearch Laboratories: RayStation
12 November 2018
Radiotherapy planning and verification systems
Model: RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
MHRA reference: 2018/011/014/701/015
Sartorius: Minisart® NML
14 November 2018
Infusion & transfusion, administration sets
MHRA reference: 2018/011/015/487/015
Stryker: LFIT Anatomic CoCr V40 Femoral Heads
18 October 2018
Joint prosthesis, hip
MHRA reference: 2018/011/013/291/008
Talley Group: Venturi Compact
08 November 2018
Active wound management
MHRA reference: 2018/011/016/291/002
Thermo Fisher Scientific: Oxoid Thermo Scientific CLED Agar + Andrades Indicator
08 November 2018
IVDs, bacteriology
MHRA reference: 2018/011/009/601/009
Volcano Corporation (Philips): Visions PV .035 IVUS Catheter
09 November 2018
Ultrasound, imaging
MHRA reference: 2018/011/013/291/009
Zimmer: NexGen Distal Femoral Augment Block
09 November 2018
Joint prosthesis, knee
MHRA reference: 2018/011/009/487/013