Medical device recalls Moderate risk

Mozarc Medical US LLC recalls Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Recall date
April 23, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1888-2025
FDA classification
Class II
Brand / firm
Mozarc Medical US LLC
Sold / distributed
Worldwide distribution - US Nationwide and the countries of Canada & Mexico.

Why it was recalled

Potential breach of sterile barrier packaging.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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