Product Wiki · Recalls · Health Canada — Medical Devices

Homechoice Automated PD System and Homechoice Pro Automated PD System… — recall 57214

Health Canada — Medical Devices · Canada · 2017-08-14 · Type II

As described by Health Canada — Medical Devices: Homechoice Automated PD System and Homechoice Pro Automated PD System (2017-07-10)

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Agency
Health Canada — Medical Devices
Recall identifier
57214
Date of alert
2017-08-14
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: Baxter Corporation has been made aware that users may not be following the instructions in the operator's manual and incorrectly opening disposable set packaging while setting up their peritoneal dialysis (PD) therapy, damaging the cassettes for the Homechoice or Homechoice Pro System. If damaged cassettes are used, the cyclers may not consistently detect very small holes/cuts in the sheeting of the cassette in the patient valve region, and the cycler may deliver air into the patient.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/homechoice-automated-pd-system

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