FDA Medical Device Recalls (openFDA)
Mozarc Medical US LLC: Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
- Recall number
- Z-1887-2025
- Recalling firm
- Mozarc Medical US LLC
- Product
- Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
- Status
- Open, Classified
- Initiated
- 2025-04-23
- Posted
- 2025-05-30
- Terminated
- not on file
- 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 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.
- Quantity
- 95,938 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
- Lot, serial or model codes
- Model No.8888133508P, 8888123408P, 8888119368P, 8888128458P; UDI: 20884521157931, 20884521157795, 20884521157726, 20884521157863; Serial No. 2234800132, 2302500141, 2302500148, 2305300142, 2305300144, 2305300177, 2313800083, 2324100168, 2324100310, 2324100311, 2405800229, 2426300218, 2426700122, 2427700199.
- 510(k) numbers
- ["K123196"]
- PMA numbers
- not on file
- Product code
- MSD
- Firm FEI
- 3030574705
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28