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Health Canada Medical devices

Z-Med II-X Catheter

Issued October 30, 2024
Issue
These units are being recalled due to them being manufactured with the incorrect balloon. The balloon that was placed on this catheter has a lower rated burst pressure than what the PDZ733 is labeled for. The size and length are correct, but the labeled rated burst pressure is different. Recall Start Date: October 25, 2024
Hazard description
Performance
Product
Product name
Z-Med II-X Catheter
Reference
ID
RA-76408