Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Summary
The FDA issued a Class II for Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque uret by Mozarc Medical US LLC. Reason: Potential breach of sterile barrier packaging..
Details
Source
Device Recall
External ID
Z-1888-2025
Action Date
2025-06-11
Status
Ongoing
Category
device
Product Description
Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Lot/Code Info: 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.
Quantity Affected: 95,938 units
Reason for Recall
Potential breach of sterile barrier packaging.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-23
Company
Mansfield, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Mozarc Medical US LLC has 12 FDA actions in our database, including 12 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mozarc Medical US LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mozarc Medical US LLC have FDA actions?
Mozarc Medical US LLC has 12 FDA actions in our database, including 12 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1888-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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