Field Safety Notices - 20 February - 24 February 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 20 February - 24 February 2017

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

Acumed: Acumed 045" X 6" ST & 054" X 7" ST Guide Wire

20 February 2017

Osteosynthesis, skeletal pins, wires and staples

Model: 45-0029-S & 45-0031-S

MHRA reference: 2017/002/022/291/002

B. Braun Surgical: Bone Wax Stick

15 February 2017

Bone cement and tools

Model: 1029755

MHRA reference: 2017/002/013/601/003

Bauch& Lomb: Laseredge trapezoidal Knife

23 February 2017

Surgical Instruments, non-articulated cutting

MHRA reference: 2017/002/016/701/015

Cordis Cashel: Smartflex

16 February 2016

Implants, non-active, peripheral vascular stents

Model: Peripheral Vascular Stent

Smartflex

MHRA reference: 2017/002/017/291/009

Encore Medical: RSP Monoblock Fixture

14 February 2017

Orthopaedic surgical instruments - insertion/extraction tools

Model: Insertion Instrument

MHRA reference: 2017/002/021/701/009

GE Medical: RFX/SFX, Legacy, Precision 500D

GEHC Ref# FMI 10908

X-ray, fluoroscopy systems

MHRA reference: 2017/002/020/701/013

Guardian Surgical: Guardian

16 February 2017

Basic dressings, absorbents, swabs, procedure packs

Model: Guardian; CHX001/001, CHX002/002, RO015456, 15.12.116, 15.88.002

MHRA reference: 2017/002/009/601/010

LeMaitre Vascular: Reddick Catheters

17 February 2017

Vascular cannula and catheters

Model: 2401-50, 2401-51, 2401-52, 2401-53

MHRA reference: 2017/002/020/701/012

Nipro Corporation: Hypodermic Needle/ Safety Hypodermic needle

20 February 2017

Injection devices

Model: HN-SF 1925 ET/HN-1925-ET/HN19-38-ET

MHRA reference: 2017/002/020/701/021

Ortho Solutions: AFN Nail Alignment Shaft

23 February 2017

Orthopaedic Surgical instruments - Insertion/extraction tools

Model: OS333503

MHRA reference: 2017/002/023/701/013

Phadia: EliA Sample Diluent, ImmunoCAP Specific IgA/IgG Sample Diluen

QA2017-01

IVDs, immunology

MHRA reference: 2017/002/001/601/022

Siemens Healthcare: ADVIA Chemistry LDLP and LDPL Reagent

February 2017

IVDs, clinical chemistry

MHRA reference: 2017/002/015/601/005

Synergy: Plain Fast Edge Ribbon Gauze

17 February 2017

Basic dressings, absorbents, swabs

MHRA reference: 2017/002/020/701/011

Thoratec Corporation: HeartMate PHP™ Percutaneous Heart Pump Catheter

6 February 2017

Cardiac assist pumps

MHRA reference: 2017/002/007/291/006

Tornier SAS: Radial Head Prosthesis

17 February 2017

Joint prosthesis, elbow

Model: Radial Head Prosthesis; Stem / Neck

MHRA reference: 2017/002/017/291/008

Zimmer Biomet: Comprehensive Reverse Shoulder Tray

1 February 2017

Joint prosthesis, shoulder

MHRA reference: 2016/012/030/701/004

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