Product Wiki · Recalls · Health Canada — Medical Devices

BARDEX I.C. 2-WAY FOLEY CATHETERS (2015-12-23) — recall 54809

Health Canada — Medical Devices · Canada · 2016-01-22 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54809
Date of alert
2016-01-22
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: Bard is notifying customers that the instructions for use (IFU) included with the named BARDEX I.C. 2-way Foley catheters and 2-way Council tip Foley catheters distributed by the manufacturer from June 2013 to June 2015 provide the incorrect inflation volume. The inflation volume provided on the catheter's valve cap does state the correct inflation volume.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/bardex-ic-2-way-foley-catheter

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