URGENT FIELD SAFETY NOTICE BDDS-18-1286

Urgent Field Safety Notice MindFrame CaptureTM LP All model and lot numbers Recall March 2018 Medtronic reference: FA804 Dear Health Care Professional, Risk Manager, Medtronic

Item Code Product Description FGS-0312 Bravo® pH capsule delivery device, 5-pack FGS-0313 Bravo® pH capsule delivery device, 1-pack Medtronic is adding the following statement to

Device Model/Catalogue/part numbers Product code - RPN GPN Description IGTCFS-65-2-UNI-TULIP G52926 Günther Tulip® Vena Cava Filter Set for Femoral and Jugular Vein Approach

Image 2 – SN location on the Affinity Fusion Oxygenator Product Number Product Description Device Identification BB811 Oxygenator with Balance Biosurface All Fusion Oxygenator

Page 1 of 4 FSN & FSCA Ref: 2019FA0010 © COPYRIGHT DOCUMENT Urgent Field Safety Notice Product Removal – Transjugular Intrahepatic Set For Attention of: Chief Executive / Risk

Advice on action to be taken by Healthcare Professionals using the BD Vacutainer® EclipseTM SignalTM with Integrated Holder:  Undertake an assessment within your healthcare

URGENT FIELD SAFETY NOTICE Product description: Human IgM Kit for use on SPAPLUS, Product codes NK012.S and NK012.10S FSCA Identifier 12580 Type of Action - Advisory 14th

DIR XXXXXXXXX Ver A Date WA-MOD1299R-XXXX Customer name Customer Street Address Customer Country, Zip Commercial name of affected product: Welch Allyn Patient Cables or Lead Sets