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U.S. Department of Health and Human Services

Class 2 Device Recall MAHURKAR"

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 Class 2 Device Recall MAHURKAR"see related information
Date Initiated by FirmOctober 17, 2025
Date PostedNovember 04, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0423-2026
Recall Event ID 97848
510(K)NumberK192302 
Product Classification Catheter, hemodialysis, triple lumen, non-implanted - Product Code NIE
ProductMAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Code Information REF Number: 8888101003HP; UDI-DI: (Individual unit) 10884521127975, (Carton) 20884521127972; Lot number: 2424500194, 2430500018;
Recalling Firm/
Manufacturer		 Mozarc Medical US LLC
15 Hampshire St
Mansfield MA 02048-1113
Manufacturer Reason
for Recall		A potential issue with the seal integrity of header bag packaging.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn October 17, 2025, URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Required Actions: 1. Immediately quarantine and discontinue use of unused affected product. 2. Please complete and return the Customer Response Form (Attachment 1), regardless of whether unused inventory is available. 3. If you have unused inventory, please contact Customer Care at 1-877-211-1850 or via email uscustomercare@mozarcmedical.com to request an RGA. Please copy your local sales representative on this email. 4. Share this notice with those who need to be aware within your organization or to any organization including, but not limited to, surgeons, interventionalists, or other staff. Please maintain a copy of this notice in your records. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have questions regarding this communication, please contact your local representative or Customer Care at 1-877-211-1850, option 1 (Monday Friday 8:00 a.m. to 5:00 p.m. CST).
Quantity in Commerce3,258 units
DistributionUS Nationwide distribution.
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 = NIE
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