Z-1888-2025Class II

Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter

Name: Z-1888-2025 Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter
Creator: Mozarc Medical US LLC
Published: 2025-04-23
License: https://open.fda.gov/license/

Mozarc Medical US LLC / initiated 2025-04-23 / Open, Classified / root cause: packaging

FDA source

Mozarc Medical US LLC began a recall of Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter on 2025-04-23. FDA classified it as Class II and gives the reason as "Potential breach of sterile barrier packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1888-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-23
Posted: 2025-05-30
Recalling firm: Mozarc Medical US LLC
Product: Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Product code: MSD Catheter, Hemodialysis, Implanted
Reason for recall: Potential breach of sterile barrier packaging.
Root cause tag: packaging
FDA 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 [email protected]. Consignees with questions about the recall can contact Medtronic Customer Care at 877-211-1850.
Quantity in commerce: 95,938 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
Product codes and lots: Model No.8888123405P, 8888123411P, 8888128455P, 8888128461P, 8888119365P, 8888119371P, 8888133505P; UDI: 20884521157788, 20884521157825, 20884521157856, 20884521157894, 20884521157719, 10884521157750, 20884521157924; Lot/Serial No. 2204000102, 2228000068, 2228000070, 2234800148, 2234800159, 2234800160, 2302500128, 2305300136, 2315600104, 2315600113, 2315600119, 2315600122, 2318500135, 2318500136, 2318500140, 2320000255, 2332700275, 2335200414, 2412000238, 2412000239, 2414300228, 2414300233, 2418000150, 2426300169.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1888-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1885-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-05-30
Z-1886-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-05-30
Z-1887-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-05-30
Z-1888-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-05-30
Z-1889-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-05-30

Product code MSD

K123196Class IIPalindrome Precision H Chronic Catheter, Palindrome Precision Si Chronic Catheter, Palindrome Precision Hsi Chronic CathCovidien / cleared 2013-01-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)