MAHURKAR 8888104004HP (UDI 10884521832817)Recalls & reported problems

Mozarc Medical US LLC · Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components · Class 2

All models of MAHURKAR (81)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

31 other recalls cover devices cleared under the same FDA submission (K102605, K192302); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Oct 17, 2025Class IIOpen, Classified
A potential issue with the seal integrity of header bag packaging.
Z-0426-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102605, K192302. One submission often covers many models, so check the product and lot details in each record.

Z-0423-2026 · Oct 17, 2025 · Open, Classified
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Z-0424-2026 · Oct 17, 2025 · Open, Classified
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Z-0421-2026 · Oct 17, 2025 · Open, Classified
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
Z-0425-2026 · Oct 17, 2025 · Open, Classified
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Z-0422-2026 · Oct 17, 2025 · Open, Classified
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
Z-2390-2023 · Jun 28, 2023 · Open, Classified
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637
Z-2380-2023 · Jun 28, 2023 · Open, Classified
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637
Z-2372-2023 · Jun 28, 2023 · Open, Classified
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
Z-2389-2023 · Jun 28, 2023 · Open, Classified
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888345629HP
Z-2391-2023 · Jun 28, 2023 · Open, Classified
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP
Z-2377-2023 · Jun 28, 2023 · Open, Classified
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP
Z-2373-2023 · Jun 28, 2023 · Open, Classified
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP
Z-2369-2023 · Jun 28, 2023 · Open, Classified
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003HP
Z-2375-2023 · Jun 28, 2023 · Open, Classified
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 8888103004HP
Z-2388-2023 · Jun 28, 2023 · Open, Classified
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629

…and 16 more.

Device details

UDI-DI	`10884521832817`
Brand	MAHURKAR
Model	8888104004HP
Company	Mozarc Medical US LLC
Product code	NIE · Catheter, hemodialysis, triple lumen, non-implanted
Class	Class 2
FDA submission	K102605, K192302
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 16, 2025

Device type (GMDN): Triple-lumen haemodialysis catheter

A sterile, flexible, triple-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access to: 1) conduct blood from a patient and return it after extracorporeal circulation, primarily during haemodialysis, but may also be intended for haemoperfusion and/or apheresis; and 2) enable central venous access for intravenous (IV) administration and/or invasive venous blood pressure monitoring. It includes three lumens, two dedicated to coaxial flow of blood for dialysis, and the third intended for independent IV access. Devices dedicated to catheter introduction/function may be included. This is a single-use device.

Other Catheter, hemodialysis, triple lumen, non-implanted devices

Power-Trialysis catheter 5605150
Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
2 recalls13 reports
Power-Trialysis catheter 5605240
Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
2 recalls8 reports
MAHURKAR 8888101002HP
Mozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
2 recalls1 death8 reports
Power-Trialysis Slim-Cath catheter 5855240
Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
2 recalls4 reports
Power-Trialysis catheter 5615200
Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
2 recalls4 reports
MAHURKAR 8888101003HP
Mozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
2 recalls4 reports
MAHURKAR 8888102003HP
Mozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
2 recalls4 reports
MAHURKAR 8888102004HP
Mozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
2 recalls3 reports

All Catheter, hemodialysis, triple lumen, non-implanted devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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