Reported Jun 11, 2025 · Ongoing
Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Mozarc Medical US LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mozarc Medical US LLC · 15 Hampshire St · Mansfield, MA · 02048-1113
Is this the product you have?
- Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 8888133508P8888123408P, 8888119368P, 8888128458P — 20884521157931208845211577952088452115772620884521157863UDI: 20884521157931, 20884521157795, 20884521157726, 20884521157863 — Serial No. 2234800132, 2302500141, 2302500148, 2305300142, 2305300144, 2305300177, 2313800083, 2324100168, 2324100310, 2324100311, 2405800229, 2426300218, 2426700122, 2427700199. - Amount recalled
- 95,938 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Potential breach of sterile barrier packaging.
This product could cause temporary or reversible health problems — stop using it.
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