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

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

Published 21 September 2020