Field Safety Notices: 14 to 18 January 2019
List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 January 2019
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: HeartMate 3™ Left Ventricular Assist System
07 January 2019
Implantable ventricular assist devices
Model: 106524INT HM3 LVAS Kit
MHRA reference: 2018/004/009/291/032
Balt Extrusion: ECLlPSE2l
21 December 2018
Vascular cannula and catheters
MHRA reference: 2019/001/007/291/001
Convatec (Medtronic)
December 2018
Infusion & transfusion, administration sets
Model: Medtronic MiniMed Mio™ Advance Infusion Sets - MiniMed™ Mio™ Advance (MMT-242, MMT-242T, MMT-242600, MMT-247, MMT-247T, MMT-247600)
MHRA reference: 2018/012/020/487/003
Cook Medical: Entuit Secure Gastrointestinal Suture Anchor Set
13 December 2018
Sutures Model: Entuit
MHRA reference: 2019/001/007/701/013
Covidien (Medtronic): Parietex™ Composite Parastomal Mesh
December 2018
Surgical mesh for hernia repair.
MHRA reference: 2018/010/015/291/018
Innovative Design Orthopaedics: Long Glenoid Base Plate
01 September 2018
Joint prosthesis, shoulder
Model: 125476
MHRA reference: 2018/012/023/601/001
Innovative Design Orthopaedics: Verso Shoulder Humeral Shells and Verso Shoulder Stemmed Humeral
08 January 2019
Joint prosthesis, shoulder 124567; 124566; 124565; 124564; 124563; 124562; 124561; 124560
MHRA reference: 2019/001/007/601/002
Philips: Philips PageWriter TC Cardiographs (TC20/30/50/70)
19 December 2018
ECG
Model: The affected products are all PageWriter TC Cardiographs (TC20/30/50/70) manufactured before November 20, 2018 that are capable of operating under battery power and have lithium-ion batteries presently installed.
MHRA reference: 2019/001/015/487/001
Teleflex: Percuvance 29cm Shaft, Percuvance 36cm Shaft
14 January 2019
Surgical instruments, minimal access
MHRA reference: 2019/001/015/291/009