The United States (US) Food and Drug Administration (FDA) issued a Class I recall concerning Medpro AccuFlux Elastomeric Infusion Pump, Model CT-0020-100H, Lot 91209, manufactured by Medpro Corporation PTE LTD, Singapore.
The recall was initiated because the affected lot may have a higher flow rate than specified. The use of the affected product may lead to over-administration of drug solutions to the patients. The product may fail to meet nominal flow rate of ±15%.
For details, please refer to the following FDA website:
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=60030&w=12052012&lang=eng.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 6 December 2012