Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
FDA device recall Z-1886-2025 · posted 2025-05-30 · Open, Classified
Recall details
- Recalling firm
- Mozarc Medical US LLC
- Reason for recall
- Potential breach of sterile barrier packaging.
- Action taken
- 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.
- Root cause
- Packaging
- Status
- Open, Classified
- Product code
- MSD
- Quantity affected
- 95,938 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
- Date initiated
- 2025-04-23
- Date posted
- 2025-05-30
- Location
- Mansfield, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH (K123196) | Covidien | 2013-01-31 |