Field Safety Notices: 14 to 18 September 2020
List of Field Safety Notices (FSNs) from medical device manufacturers from 14 September to 18 September 2020
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
View a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website.
Bard: Bard® PowerMidline™ 3F SL (single-lumen) kits
09 September 2020
Vascular cannula and catheters
MHRA reference: 2020/009/011/487/002
Baxter: WRO 300H Water Purification System
14 September 2020
Dialysis, haemodialysis
Model: 955686
MHRA reference: 2020/009/011/487/008
Beckman Coulter: Access Unconjugated Estriol
14 September 2020
IVDs, clinical chemistry
MHRA reference: 2020/009/016/601/001
Blink Medical: HR620: Cannula Liposuction 30cm x 6mm,
HR621: Cannula Liposuction 30cm x 5mm, HR622: Cannula Liposuction 30cm x 4mm, HR623: Cannula Liposuction 30cm x 3mm, HR624: Cannula Liposuction 15cm x 4mm, HR625: Cannula Liposuction 15cm x 3mm, HR626: Cannula Liposuction 15cm x 2mm
09 September 2020
Surgical instruments, minimal access
Model: HR620; HR621; HR622; HR623; HR624; HR625; and HR626
MHRA reference: 2020/009/014/487/001
Boston Scientific: Hurricane RX Biliary Balloon Dilatation Catheter
92583333-FA
Surgical instruments, minimal access
MHRA reference: 2020/009/017/291/001
Brainlab: Ultrasound Navigation Software
31 August 2020
Surgical navigation system and accessories
Model: 22582; 22582A; 22582B; 22583; 26506; 26506A; 26508A
MHRA reference: 2020/009/016/487/005
Coloplast: ELEFANT® Suction/irigation device
14 September 2020
Surgical equipment, miscellaneous
Model: 64120
MHRA reference: 2020/009/014/601/001
Draeger: Perseus A500
September 2020
Anaesthetic machines & monitors
Model: Perseus A500, MK06000
MHRA reference: 2020/009/014/291/002
Exactech: Compression Screw/Locking Cap Kits
08 September 2020
Osteosynthesis, bone screws
MHRA reference: 2020/008/028/701/026
Mentor: MENTOR® Breast Tissue Expander
2 September 2020
Implants, tissue expanders
Model: CPX4
MHRA reference: 2020/009/004/291/001
Merit Medical: Prelude SNAP™; Worley™,
1721504-08/31/20-005R
Vascular cannula and catheters
MHRA reference: 2020/009/016/291/001
Smith & Nephew: Suture Base Repair Systems
11 September 2020
ligaments, tendons and anchors
MHRA reference: 2020/009/016/487/008
Steripack: Syringe 10 ml with 0,9% sodium chloride
21 August 2020
Vascular cannula/catheter accessories
MHRA reference: 2020/009/003291005
Welland Medical: Hydroframe with Manuka Honey
09 September 2020
Wound management
Model: (X)MHWAFH33
MHRA reference: 2020/009/010/601/003