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.
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
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
FSN-001
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
QIAGEN: QuantiFERON-TB Gold
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