MAHURKAR Catheter Tray (Mozarc) – Packaging Seal Integrity (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" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
Brand
Mozarc Medical US LLC
Lot Codes / Batch Numbers
REF Number: 8888101001HP, UDI-DI: (Individual unit) 10884521127890, (Carton) 20884521127897, Lot number: 2430500021
Products Sold
REF Number: 8888101001HP; UDI-DI: (Individual unit) 10884521127890, (Carton) 20884521127897; Lot number: 2430500021
Mozarc Medical US LLC is recalling MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr due to A potential issue with the seal integrity of header bag packaging.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A potential issue with the seal integrity of header bag packaging.
Recommended Action
Per FDA guidance
On 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).
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