Field Safety Notices - 19 - 23 September 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 19 - 23 September 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
AngioDynamics: Celerity Sterile Disposables
7 September 2016
ECG
MHRA reference: 2016/009/019/291/007
B Braun: Spinocath®
15 September 2016
Vascular cannula and catheters
Model: Spinocath® 4517717, 4517725
MHRA reference: 2016/009/016/601/002
Boston Scientific: Lotus™ Valve System
17 May 2016
Implants, non-active, cardiovascular heart valves
Model: H749LTV230, H749LTV250 & H749LTV270
MHRA reference: 2016/004/014/299/016
Buhlmann: Quantum Blue ® Calprotectin Assay, Quantum Blue ® Calprotectin High Range
11 August 2016
IVDs, bacteriology
MHRA reference: 2016/009/019/291/008
Cepheid: Xpert ® HIV-1 Viral Load
16 September 2016
IVDs, viral microbiology
MHRA reference: 2016/009/020/071/002
Codan: Transducer of the DPT-6000er series
12 September 2016
Infusion and transfusion, administration sets
MHRA reference: 2016/008/022/291/003
Flowonix Medical: Prometra® Programmable Pump
20 September 2016
Implants, active, infusion pumps
Model: Prometra® Pump REF 91827; Prometra®Programmer REF 91828; Catheter REF 91823
MHRA reference: 2016/009/005/299/021
ICU Medical: TEGO Connector
06 September 2016
Infusion and transfusion, connectors
MHRA reference: 2016/009/009/701/017
Lemaitre Vascular
21 September 2016
Surgical instruments, non-articulated cutting
Model: 1009-00, 1009-00J
MHRA reference: 2016/009/021/131/008
MI Tech: NES / NESA / EPW range
QF3444
Implants, non-active, non-vascular stents
Model: NES-18-080-070 / NES-18-110-070 / NESA-18-110-070 / EPW-20-100-070 / EPW-20-150-070
MHRA reference: 2016/009/020/601/005
Ohmeda Medical: Ohio Infant Warmer Systems
GEHC Ref# 32047
Infant, warmers
Model: Model 2001 IWS (International), 3000 IWS, 3050 IWS, 3100 IWS, 3150 IWS, 3300 IWS, 3500 IWS, 4000 IWS, 4300 IWS, 4400 IWS, 5000 IWS.
MHRA reference: 2016/009/016/29
Philips Healthcare
September 2016
Monitors, patient
Model: MX40
MHRA reference: 2016/009/019/291/034
RaySearch Laboratories
FSN 12171_11861
Radiotherapy planning and verification systems
Model: 2.5, 3.0, 3.5, 4.0, 4.3, 4.5, 4.7, 5.0
MHRA reference: 2016/009/020/701/001
Randox: Evidence Investigator EV3602, EV3602R
02 August 2016
IVDs, clinical chemistry
MHRA reference: 2016/009/019/601/001
Randox: Magnesium on RX Imola MG3880
6 April 2016
IVDs, clinical chemistry
MHRA reference: 2016/009/019/601/002
Roche: Diverse Instruments - Rack Trays
12 September 2016
IVDs, clinical chemistry
MHRA reference: 2016/009/019/701/003
Roche: Cobas c 111
14 September 2016
IVDs, clinical chemistry
Model: Cobas c 111 04528778001/04777433001
MHRA reference: 2016/009/019/701/011
Sofradim Production: Refer to the FSN
14 September 2016
Implants, non-active, abdominal & hernia mesh
Model: Abdominal hernia surgical mesh Parietex™ Plug and Patch System and ProGrip™ Self-Gripping Polyester Mesh
MHRA reference: 2016/009/013/701/002
Trinity Biotech: MicroTrak® Syphilis TPHA PK
20 September 2016
IVDs, bacteriology
Model: D268003
MHRA reference: 2016/009/019/291/029