Product Wiki · Recalls · Health Canada — Medical Devices

FMS Sterile Intermediary Tubing (2013-08-30) — recall 50462

Health Canada — Medical Devices · Canada · 2013-09-27 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
50462
Date of alert
2013-09-27
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Internal testing has found that the check valve (Pillow valve) included in the FMS (Fluid Management System) intermediary tubing set may not be performing as intended. If the controls described in the operator's manual are not followed, this defect may result in backflow of irrigation fluid into the one-day set which may potentially lead to patient cross-contamination.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/fms-sterile-intermediary-tubin

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