FDA Medical Device Recalls (openFDA)
Mozarc Medical US LLC: MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
- Recall number
- Z-0422-2026
- Recalling firm
- Mozarc Medical US LLC
- Product
- MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
- Status
- Open, Classified
- Initiated
- 2025-10-17
- Posted
- 2025-11-04
- Terminated
- not on file
- Reason
- A potential issue with the seal integrity of header bag packaging.
- Root cause
- Under Investigation by firm
- Action
- 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).
- Quantity
- 3,258 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- REF Number: 8888101002HP; UDI-DI: (Individual unit) 10884521127968, (Carton) 20884521127965; Lot number: 2430500017;
- 510(k) numbers
- ["K192302"]
- PMA numbers
- not on file
- Product code
- NIE
- Firm FEI
- 3030574705
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28