Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Recall
- Recall Number
- Z-1885-2025
- Event Number
- 96809
- Firm
- Mozarc Medical US LLC
- FEI Number
- 3030574705
- Product Code
- MSD
- Status
- Open, Classified
- Root Cause
- Packaging
- Initiated
- April 23, 2025
- Posted
- May 30, 2025
- Address
- 15 Hampshire St, Mansfield, MA, 02048-1113
Description
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Potential breach of sterile barrier packaging.
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 [email protected]. Consignees with questions about the recall can contact Medtronic Customer Care at 877-211-1850.
Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
95,938 units