Palindrome Precision SI Chronic Hemodialysis Catheter recall: Sterility Concern
Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Why was Palindrome Precision SI Chronic Hemodialysis Catheter recalled?
Potential breach of sterile barrier packaging.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
- Recalling firm
- Mozarc Medical US LLC
- Quantity
- 95,938 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
- Recall date
- June 11, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)