MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm
FDA device recall Z-0422-2026 · posted 2025-11-04 · Open, Classified
Recall details
- Recalling firm
- Mozarc Medical US LLC
- Reason for recall
- A potential issue with the seal integrity of header bag packaging.
- 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).
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NIE
- Quantity affected
- 3,258 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2025-10-17
- Date posted
- 2025-11-04
- Location
- Mansfield, MA
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