Product Wiki · Recalls · Health Canada — Medical Devices

Ambulatory Infusion Pumps (2015-12-24) — recall 54760

Health Canada — Medical Devices · Canada · 2016-01-25 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54760
Date of alert
2016-01-25
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: The master pumps used to calibrate manufactured and serviced pumps have a calibration shift of up to 6.8% (+3%). When an affected master pump is used to calibrate production and serviced pumps, this pump is used to calibrate production and serviced pumps, this calibration shift could lead to over delivery of fluid beyond the label claim of +5%.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ambulatory-infusion-pumps-2015

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