Field Version Corrective Action
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Medical Device Information Class AIMD Active Implants MDD Class III IVD Annex II List A MDD Class IIb IVD Annex II List B MDD Class IIa IVD Devices for Self-Testing MDD Class I IVD General Nomenclature System (preferable GMDN) GMDN Nomenclature Code 35127 Nomenclature Text Intravenous fluid container, single use Commercial Name/ Brand Name / Make CADD™ Medication Cassette Reservoir Model Number N/A Catalogue Number 21-7001-24, 21-7301-24 Serial Number(s) N/A Lot/ Batch Number(s) 21-7001-24, Lot Numbers 14X-297 and 14X-323.. 30 October 2015 Date Signature Ellen Riebe Name St. Paul, MN City Page 4 of 5 Field Safety Corrective Action Report Form Medical Devices Vigilance System (MEDDEV 2.12/1 rev 8) v.01.13 Submission of this report does not, in itself, represent a conclusion by the manufacturer and / or authorized representative or the National Competent Authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person..
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