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
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