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Health Canada Medical devices

Palindrome Precision Sport Packs

Issued May 8, 2025
Issue
Cardinal Health Canada has been notified of an urgent product recall initiated by Mozarc Medical US LLC, formerly Medtronic - Renal Care Solutions. Mozarc Medical is voluntarily initiating a recall for specific lots of the Palindrome™ Precision Sport Pack Packaging configuration. This action is being taken to prevent the use of potentially affected products. Specific Sport Pack product lots of Palindrome™ Precision, Palindrome™ Precision H, Palindrome™ Precision HSI and Palindrome™ Precision SI catheter product configurations may exhibit a potential breach in pouch seal integrity. This issue is limited to the Sport Pack Palindrome™ Precision configuration only and does not affect the kit packaging for Palindrome Precision and Palindrome Kit and Sport Pack packaging configurations. Recall Start Date: April 25, 2025
Hazard description
Sterility
Product
Product name
Palindrome Precision Sport Packs
Reference
ID
RA-77424