Field Safety Notices - 23 January - 27 January 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 23 - 27 January 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

Applied Medical Technology (Use GBUK Healthcare for UK incidents): AMT Bridle - Nasal Tube Retaining System

23 January 2017

Feeding systems and tubes

MHRA reference: 2017/001/026/291/004

Becton Dickinson: BD Plastipak Syringe/ BD Oral Syringe

January 2017

Injection devices

MHRA reference: 2015/009/022/601/003

Becton Dickinson: BD Plastipak™ Syringe, CT with Luer Slip Adaptor

MSS-16-730-FA

Injection devices

MHRA reference: 2017/001/024/701/005

bioMerieux: Etest® References listed Anne 1

16 January 2017

IVDs, bacteriology

MHRA reference: 2016/012/028/071/001

bioMérieux: Etest® XM256 (Cefuroxime)

FSCA 3303

IVDs, bacteriology

MHRA reference: 2017/001/024/291/001

bioMérieux: BK Virus R-gene® Real-time Detection and Quantification Kit

23 January 2017

IVDs, viral microbiology

MHRA reference: 2017/001/024/291/002

Corpak MedSystems: CORFLO* PEG Adapter with ENFit Connectors

16 January 2017

Feeding systems and tubes

MHRA reference: 2017/001/020/291/014

Covidien: Devon™ Light Glove

9 January 2017

Lamps and lights

Model: Devon™ Light Glove

MHRA reference: 2017/001/006/701/015

Diagnostica Stago: STA ® -Cuvettes

January 2017

Coagulation

MHRA reference: 2017/001/026/291/002

Endolologix International Holdings: AFX EndoVascular AAA System

December 2016

Implants, non-active, endoprostheses for aortic aneurysms

Model: All models

MHRA reference: 2016/012/022/601/002

Ethicon: ETHICON PERMA-HAND ® (or MERSILK™) Silk Suture

23 January 2017

Sutures

MHRA reference: 2017/001/023/701/010

Integra LifeSciences (Ascension Orthopedics): Integra ®Cadence ®Total Ankle System

25 January 2017

Joint prosthesis, ankle

Model: various models

MHRA reference: 2017/001/017/701/028

Medicina: Silo bag

6 January 2017

Surgical devices, non-powered

Model: SBxx

MHRA reference: 2017/001/009/601/003

Medline International: Sterile Procedure Trays

FSCA-17/01

Lamps and lights

Model: Sterile procedure trays

MHRA reference: 2017/001/023/291/004

Mölnlycke : ProcedurePak ® trays containing Light Handle Cover (Devon™ Light Glove); See attached Product Table

20 January 2017

Lamps and lights

Model: MHRA reference: 2017/001/020/701/012

Occlutech: Occlutech Occlusions-Pusher, Flex-Pusher II

23 January 2017

Implants, non active, cardiac appendage and septal defect occluders / plugs

MHRA reference: 2017/001/013/299/025

Philips: Cisco 3850 layer 3 switch (WS-C3850-12S-E) with Incompatible Interconnect cable

December 2016

Monitors, patient

MHRA reference: 2017/001/020/291/002

RaySearch: RayStation

18 January 2017

Radiotherapy planning and verification systems

Model: 4.5, 4.7, 5.0, 6.0

MHRA reference: 2017/001/020/701/014

Robinson Healthcare: Instrapac

26 January 2016

Surgical instruments, minimal access

Model: Instrapac; 8258

MHRA reference: 2017/001/026/601/002

Schölly Fiberoptic: EinsteinVision® 3D-Endoskopie-System

25 January 2017

Endoscopes, televisual systems

MHRA reference: 2017/001/026/701/001

Stanmore: Custom-made Medical Device - Glenoid Shell & Proximal Humeral Replacement

20 January 2017

Joint prosthesis, shoulder

Model: PIN 20391

MHRA reference: 2017/001/023/299/002

Vygon: GTUBE 12FG 2L DEHP FREE

26 January 2017

Feeding systems and tubes

Model: VWJKC0100-12LVF

MHRA reference: 2017/001/026/601/003

Wallac: DELFIA Xpress PlGF 1-2-3

25 January 2017

IVDs, clinical chemistry

Model: 6007-0030, 6007-003C

MHRA reference: 2017/001/025/291/013

Zimmer Biomet: Vanguard Open Box Femoral Component

4 January 2017

Joint prosthesis, knee

MHRA reference: 2017/001/023/701/005

Zimmer Biomet: TAPERLOC MICROPLASTY RASP 10 x105mm

15 December 2016

Surgical instruments, non-articulated cutting

MHRA reference: 2017/001/024/701/004

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