Mozarc Medical US LLC: Device Recall
Recall #Z-1887-2025 · 04/23/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1887-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Mozarc Medical US LLC
- Status
- Ongoing
- Date Initiated
- 04/23/2025
- Location
- Mansfield, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 95,938 units
Reason for Recall
Potential breach of sterile barrier packaging.
Product Description
Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
Other Recalls by Mozarc Medical US LLC
- Class II: Risk 10/17/2025
- Class II: Risk 10/17/2025
- Class II: Risk 10/17/2025
- Class II: Risk 10/17/2025
- Class II: Risk 10/17/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.