Product Wiki · Recalls · Health Canada — Medical Devices

Animas 2020 Insulin Infusion Pump — recall 48903

Health Canada — Medical Devices · Canada · 2013-02-04 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
48903
Date of alert
2013-02-04
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: A small number of Animas 2020 Insulin Infusion Pumps are potentially affected by a misalignment of a component on the printed circuit board assembly. This component misalignment results in the Insulin Pump potentially measuring force conditions incorrectly, resulting in false warnings and/or alarms. Should the patient complete a load sequence or prime the insulin infusion pump and does not disconnect from the infusion set from the body, the insulin infusion pump may dispense all of the insulin in the cartridge into the patient. There is no safety risk as long as the patient follows the instructions for use and always disconnects the infusion set prior to priming the pump, changing the cartridge, and rewinding the motor.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/animas-2020-insulin-infusion-p

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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