Z-0424-2026Class II

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch...

Name: Z-0424-2026 MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch...
Creator: Mozarc Medical US LLC
Published: 2025-10-17
License: https://open.fda.gov/license/

Mozarc Medical US LLC / initiated 2025-10-17 / Open, Classified / root cause: packaging

FDA source

Mozarc Medical US LLC began a recall of MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm on 2025-10-17. FDA classified it as Class II and gives the reason as "A potential issue with the seal integrity of header bag packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0424-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-17
Posted: 2025-11-04
Recalling firm: Mozarc Medical US LLC
Product: MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Product code: NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Reason for recall: A potential issue with the seal integrity of header bag packaging.
Root cause tag: packaging
FDA 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 [email protected] 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 commerce: 3,258 units
Distribution: US Nationwide distribution.
Product codes and lots: REF Number: 8888102003HP; UDI-DI: (Individual unit) 10884521127999, (Carton) 20884521127996; Lot number: 2418000195;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0424-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0421-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-12	2025-11-04
Z-0422-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-12	2025-11-04
Z-0423-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-12	2025-11-04
Z-0424-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-12	2025-11-04
Z-0425-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-12	2025-11-04
Z-0426-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-12	2025-11-04

Product code NIE

K192302Class IIMahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterCovidien, LLC / cleared 2020-01-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)