Field safety notices - 30 November to 4 December 2015

List of field safety notices (FSNs) from medical device manufacturers from 30 November to 4 December 2015

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.

See more information on what an FSN is and why it’s important.

Latest FSNs

View the latest FSNs

ArcRoyal: BD PLASTIK Syringe, BD Oral syringe - included in ArcRoyal procedure packs

6 October 2015

Surgical devices, non-powered

Model: 10-000045, 10-000085, 10-000044, 10-000123

MHRA reference: 2015/012/002/291/002

BIOMERIEUX: Etest® Piperacillin/Tazobactam (4 μg/mL) PTc 0.016-256

FSCA 2709

IVDs, bacteriology

MHRA reference: 2015/011/026/299/004

Boston Scientific: Chariot™ Guiding Sheath

27 November 2015

Vascular cannula and catheters

Model: See FSN

MHRA reference: 2015/011/023/292/008

Boston Scientific: IntellaTip MiFiTM XP Temperature Ablation Catheter

27 November 2015

Therapy tissue ablation

Model: Various

MHRA reference: 2015/011/025/292/016

CIVCO Medical Instruments

23 November 2015

Phacoemulsification / Vitrectomy systems

MHRA reference: 2015/011/027/292/019

Cook Medical: EchoTip® Ultra Endobronchial High Definition Ultra ECHO-HD-22-EBUS-O, ECHO-HD-25-EBUS-O

25 November 2015

Surgical Instruments, minimal access

Model: EchoTip® Ultra Endobronchial High Definition Ultra needles

MHRA reference: 2015/012/002/291/004

Depuy Synthes: Insertion Handle for PFN

18 November 2015

Surgical Instruments, Implant

MHRA reference: 2015/012/003/291/010

Diamex: Optitrol A Multimarker Control

13 November 2015

IVDs, bacteriology

Model: Optitrol A Multimarker Control (IN0202, IN0203, IN0204)

MHRA reference: 2015/011/026/701/009

Draeger: Evita Infinity V500, Babylog VN500, Evita V300

November 2015

Lung ventilators

MHRA reference: 2015/011/026/292/009

Elekta

FCA-EIAB-0003

Radiotherapy

Model: Leksell GammaPlan

MHRA reference: 2015/011/026/181/002

Intervene: Intervene Surety Lock Syringe - 05011050

24 November 2015

Injection devices

Model: Intervene Surety Lock Syringe - 05011050

MHRA reference: 2015/006/005/291/009

Intuitive Surgical:

1 December 2015

Endoscopes, Rigid

Model: 8mm endoscope, 0° - 8mm endoscope, 30°, 470026-34 — 470026-40 — 470026-41 — 470027-34 — 470027-40 — 470027-41 — 470026-34 — 470026-40 — 470026-41 — 470027-34 — 470027-40 — 470027-41

MHRA reference: 2015/012/002/701/004

Leica Biosystems

25 November 2015

IVDs, cytopathology & histopathology

Model: DS9390 Bond™ Polymer Refine Red Detection

MHRA reference: 2015/011/027/601/001

Maquet: Maquet Heater and Maquet Heater/Cooler Systems

30 November 2015

Infusion & transfusion, heart lung circuits

Model: HU35, HCU20, HCU30, HCU40

MHRA reference: 2015/012/001/292/010

Mathys: Hemihead SS 48 M

2 December 2015

Joint prosthesis, hip

MHRA reference: 2015/012/002/292/014

Origio A/S (2760): Flushing Medium

23 November 2015

Laboratory equipment associated with IVF, Cells, Tissues

Model: Flushing Medium (1076/1084)

MHRA reference : 2015/011/030/291/001

Pheonix Surgical Instruments

9 November 2015

Airway devices

Model: Silver Tracheostomy Tubes

MHRA reference: 2015/001/006/401/002

Philips: Philips IntelliVue Information Center iX

20 November 2015

Monitors, Patient

Model: 866023 IntelliVue Info Center iX, A.0, 866117 PIIC Classic Upgrade,

866389 IntelliVue Info Center iX, B.0

MHRA reference: 2015/011/030/292/012

Sunrise Medical: JCM

19 November 2015

Supportive seating

Model: JCM Triton, Neptune, Pluton

MHRA reference: 2015/011/017/131/003

Synthesia: Cellistypt, Cellistypt O-K a Cellistypt F

BB30102015

Implants, Non active, vascular haemostasis MHRA reference: 2015/011/025/292/010

Thermofisher Scientific: Oxoid Antimicrobial Susceptibility Testing Disc QD15 Quinupristin / Dalfopristin (CT1644B)

1 December 2015

IVDs, bacteriology

MHRA reference: 2015/012/002/601/009

Unomedical: Various Nebulizers and Nebulization Kits including Opti-Mist / Economist II (see Attachment A for full details)

19 November 2015

Nebulizers

MHRA reference: 2015/011/020/051/003

UTECH

20 September 2015

Diagnostic measurement and monitoring

Model: Temperature probes by UTECH CO.LIT

MHRA reference: 2015/011/013/292/004

Verathon: BladderScan® BVI 9600 and AortaScan ®

1 December 2015

Ultrasound, Imaging

Model: BVI 9600 and AMI 9700

MHRA reference: 2015/012/002/292/002

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