Mahurkar Hemodialysis Catheter (Mozarc) – Sterility Breach (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Brand
Mozarc Medical US LLC
Lot Codes / Batch Numbers
Model No.8888133502, UDI: A8845210569201, Lot/Serial No. 241760200.
Products Sold
Model No.8888133502; UDI: A8845210569201; Lot/Serial No. 241760200.
Mozarc Medical US LLC is recalling MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. due to Potential breach of sterile barrier packaging.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential breach of sterile barrier packaging.
Recommended Action
Per FDA guidance
An URGENT: MEDICAL DEVICE RECALL notification dated April 2025 was mailed to consignees on 4/23/25. This notification recommends that clinicians follow facility-specific policies and procedures for routine assessment of the hemodialysis access device for patency, function, and efficacy, as well as for monitoring patient status. Consignees are instructed to immediately quarantine and discontinue use of affected devices in inventory. Consignees are to complete the electronic Customer Confirmation form to facilitate obtaining a Return Goods Authorization number for recalled devices to be returned for credit or replaced. Product purchased through a distributor can be arranged through the distributor. Consignees with any questions about the Customer Confirmation form can contact IQVIA by phone at 1-256-680-9942 or by email at medtronic-fa1486@iqvia.com. Consignees with questions about the recall can contact Medtronic Customer Care at 877-211-1850.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026