Recall Z-1886-2025— Mozarc Medical US LLC

Name: FDA recall Z-1886-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-23

Class II · Ongoing

Class II FDA medical device recall by Mozarc Medical US LLC, initiated 2025-04-23. It names one FDA 510(k) clearance: K123196. Product: Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.. Reason: Potential breach of sterile barrier packaging..

Recalling firm: Mozarc Medical US LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-04-23
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K123196 — PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATHCovidien·cleared 2013-01-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Potential breach of sterile barrier packaging.

Data sourced from openFDA. This site is unofficial and independent of the FDA.