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U.S. Department of Health and Human Services

Class 2 Device Recall Palindrome Precision Catheter

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 Class 2 Device Recall Palindrome Precision Cathetersee related information
Date Initiated by FirmApril 23, 2025
Date PostedMay 30, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1889-2025
Recall Event ID 96809
510(K)NumberK123196 
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
ProductMAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Code Information Model No.8888133502; UDI: A8845210569201; Lot/Serial No. 241760200.
Recalling Firm/
Manufacturer		 Mozarc Medical US LLC
15 Hampshire St
Mansfield MA 02048-1113
Manufacturer Reason
for Recall		Potential breach of sterile barrier packaging.
FDA Determined
Cause 2		Packaging
ActionAn 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.
Quantity in Commerce95,938 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada & Mexico.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MSD
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