Recall Z-1886-2025 ยท MSD Catheter, Hemodialysis, Implanted
Mozarc Medical US LLC
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
| Date | May 30, 2025 (initiated Apr 23, 2025) |
| Status | Open, Classified |
| Reason | Potential breach of sterile barrier packaging. |
| Root cause | Packaging |
| Action | 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 |
| Quantity | 95,938 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada & Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123196 | PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH Covidien, Jan 31, 2013 |