MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
This recall is currently active, issued November 4, 2025. It was issued by Mozarc Medical Us Llc.
- Company
- Mozarc Medical Us Llc
- Recall Initiated
- October 17, 2025
- Posted
- November 4, 2025
- Recall Number
- Z-0421-2026
- Quantity
- 3,258 units
- Firm Location
- Mansfield, MA
- Official Source
- View on FDA website ↗
Reason for Recall
A potential issue with the seal integrity of header bag packaging.
Distribution
US Nationwide distribution.
Lot / Code Info
REF Number: 8888101001HP; UDI-DI: (Individual unit) 10884521127890, (Carton) 20884521127897; Lot number: 2430500021
Root Cause
Under Investigation by firm
Action Taken
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).