Product Wiki · Recalls · Health Canada — Medical Devices

CADD ADMINISTRATION SETS WITH FLOW STOP (2016-05-05) — recall 55393

Health Canada — Medical Devices · Canada · 2016-05-20 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
55393
Date of alert
2016-05-20
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Smiths is notifying users of CADD Administration Sets with flow stop that these listed sets may affect flow rate when used with a variety of CADD ambulatory infusion pumps. This may result in under-delivery of medication by an average additional 5.2% beyond the labeled system delivery accuracy claim of +/- 6.0%. If drug under-delivery occurs, patients may not receive their full volume of medicinal product in the prescribed timeframe.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cadd-administration-sets-flow-

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