Field safety notices - 29 February to 4 March 2016

List of field safety notices (FSNs) from medical device manufacturers from 29 February to 4 March 2016.


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

B&D Electromedical:Nippy

29 February 2016

Anaesthetic machines & monitors

Model: Nippy 3+ Range of ventilators: Nippy 3+, Junior+, Nippy ST+ and Nippy S+

MHRA reference: 2016/003/002/292/008

Biomet Orthopaedic: Verso Shoulder Forked Retractor

16 February 2016

Surgical Instruments, Minimal Access

MHRA reference: 2016/003/001/292/008

Biosensors: BioMatrix Flex and BioMatrix NeoFlex

26 February 2016

Implants, non-active, coronary artery stents

Model: BioMatrix Flex: BMX-3511, BMX-3518, BMX-3524, BMX-4018. BioMatrix NeoFlex: BMXP-3511, BMXP-3518, BMXP-4018, BMXP-4024.

MHRA reference: 2016/002/029/292/024

Covidien: Emprint™ Percutaneous Antenna

29 February 2016

Therapy tissue ablation

MHRA reference: 2016/002/026/701/015

Depuy Synthes: Locking Screw Stardrive® Æ 1.5 mm, self-tapping, length 8 mm, stainless steel, Cortex Screw Stardrive® Æ 1.5 mm, self-tapping, length 8 mm, stainless steel, Part Number 02.214.008, 02.214.108

17 February 2016

Osteosynthesis, bone screws

MHRA reference: 2016/002/024/291/003

HemoCue A B: HemoCue Glucose 201 RT Microcuvettes

19 February 2016

IVDs, self / home testing

Model: 114701, 114703, 114704, 114706

MHRA reference: 2016/002/023/292/008

Medtronic: SynchroMed II Programmable Pump

1 March 2016

Implants, active, infusion pumps

Model: 8637-20, 8637-40

MHRA reference: 2016/003/001/291/001

Nutricia: Flocare infusion sets with ENFit transition adaptors

29 February 2016

Feeding systems and tubes

MHRA reference: 2015/012/010/302/001

Omrix Biopharmaceuticals: Omrix Pressure Regulator

29 February 2016

Surgical devices, non-powered

Model: All Pressure Regulator Models

MHRA reference: 2016/002/029/292/027

Ortho Clinical Diagnostics: ORTHO VISION™ Analyzers for ORTHO BioVue® Cassette

February 2016

IVDs, blood transfusion

MHRA reference: 2016/002/025/601/004

Roche Diagnostics: Estradiol III, Estradiol II

22 February 2016

IVDs, clinical chemistry

Model: Estradiol III, Estradiol II

MHRA reference: 2016/002/029/701/001

Smith & Nephew: RENASYS™ GO Negative Pressure Wound Therapy (NPWT)

19 February 2016

Active wound management

MHRA reference: 2016/002/025/291/014

S.R. Smith: Splash/S.R. Smith


Hoists and slings

Model: 350-0000EU, 375-0000EU

MHRA reference: 2016/003/002/292/002

Thermofisher Scientific: BRAHMS Free ßhCG KRYPTOR

18 February 2016

IVDs, clinical chemistry

MHRA reference: 2016/002/025/181/002


26 February 2016

IVDs, bacteriology

Model: QuantiFERON-TB Gold (0590-0201, 0597-0201, and 0597-0701)

MHRA reference: 2016/003/003/292/035

Villa Sistemi Medicali

18 January 2016

X Ray, fluoroscopy systems

Model: Juno DRF

MHRA reference: 2016/003/002/292/006

Zimmer: Instinct Java instruments and containers

9 February 2016

Surgical instruments, implant

MHRA reference: 2016/003/001/292/001

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