Mozarc Medical US LLC recalls Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane ca…

Potential breach of sterile barrier packaging.

Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

An URGENT: MEDICAL DEVICE RECALL notification dated April 2025 was mailed to consignees on 4/23/25. This notification recommends that clinicians follow facility-specific policies and procedures for routine assessment of the hemodialysis access device for patency, function, and efficacy, as well as for monitoring patient status. Consignees are instructed to immediately quarantine and discontinue use of affected devices in inventory. Consignees are to complete the electronic Customer Confirmation form to facilitate obtaining a Return Goods Authorization number for recalled devices to be returned for credit or replaced. Product purchased through a distributor can be arranged through the distributor. Consignees with any questions about the Customer Confirmation form can contact IQVIA by phone at 1-256-680-9942 or by email at medtronic-fa1486@iqvia.com. Consignees with questions about the recall can contact Medtronic Customer Care at 877-211-1850.

• FDA enforcement recordOfficial FDA database entry for Z-1888-2025
• FDA 510(k) clearance · K123196The device's official FDA premarket clearance record
• FDA device classification · MSDOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5540The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Mozarc Medical US LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.