Recall Z-1888-2025— Mozarc Medical US LLC

Name: FDA recall Z-1888-2025
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 H 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 H 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.