Field Safety Notice - 17 September to 21 September
List of field safety notices (FSNs) from medical device manufacturers from 17 September to 21 September
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
View the latest FSNs
Abbott: Alinity i Processing Module
14 September 2018
IVDs, clinical chemistry
MHRA reference: 2018/009/019/291/008
Alere Toxicology: Alere DDS2 Test Kit
17 September 2018
IVDs, clinical chemistry
Model: DDS2-403; DDS2-404; DDS2-407; DDS2-412
MHRA reference: 2018/009/013/601/018
CooperSurgical: Lone Star Single-Use Elastic Stays
September 2018
Surgical instruments, minimal access
MHRA reference: 2018/009/017/291/009
Corvia Medical: Inter-atrial Shunt Device (IASD) System II/ Corvia Medical, Inc.
18 September 2018
Vascular cannula and catheters
Model: PN 00261
MHRA reference: 2018/009/019/291/003
Endologix: AFX EndoVascular AAA System
19 September 2018
Implants, non active, endoprostheses
Model: All Models - informative notice - not model specific
MHRA reference: 2018/009/019/601/002
HMC Premedical (Medicina): NasoGastric feeding lube
September 2018
Feeding systems and tubes
Model: NGP8/85 & NGP8/120L & NGP10/120L
MHRA reference: 2018/005/011/401/017
Medtronic: O-arm® 1000 Surgical Imaging System (2nd edition)
September 2018
X Ray, fluoroscopy systems
Model: BI70000027, BI70000027R, BI70000027100, BI70000027100R, BI70000027120, BI70000027120R, BI70000027230, BI70000027230R, BI70000027GER, BI70000027GERR
MHRA reference: 2018/009/020/291/020
Roche: CoaguChek
17 September 2018
Coagulation
MHRA reference: 2018/008/023/291/010
Roche: Elecsys FT4 III
September 2018
IVDs, clinical chemistry
MHRA reference: 2018/009/018/701/016
Siemens Healthcare: ADVIA Chemistry Creatine Kinase Assay
September 2018
IVDs, clinical chemistry
MHRA reference: 2018/009/013/601/013
Stryker: HydroSet Injectable HA Bone Substitute
17 September 2018
Implant materials, bone substitutes
MHRA reference: 2018/009/014/701/007
Thermo Fisher Scientific: Oxoid Bacillus Cereus Selective Medium (PEMBA)
14 September 2018
IVDs, bacteriology
MHRA reference: 2018/009/019/601/007