Z-2537-2015Class II

MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Item...

Name: Z-2537-2015 MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Item...
Creator: Covidien LLC
Published: 2015-08-06
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-08-06 / Terminated / root cause: packaging

FDA source

Covidien LLC began a recall of MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Item Code: 8888104003HP Product Usage: Sterile Delivery... on 2015-08-06. FDA classified it as Class II and gives the reason as "Sterility may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2537-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-06
Posted: 2015-09-01
Terminated: 2017-06-29
Recalling firm: Medtronic, Inc.
Product: MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Item Code: 8888104003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
Product code: NGT Saline, Vascular Access Flush
Reason for recall: Sterility may be compromised
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Medtronic/Covidien sent an Urgent Medical Device Recall letter August 7, 2015 to affected customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter instructs customers to quarantine, discontinue use and return the affected product as instructed in the letter. For questions contact your Medtronic representative or Customer Service at (800)-882-5878
Quantity in commerce: 550 kits
Distribution: US Nationwide Distribution
Product codes and lots: Lot Numbers: 1504700147, 1507600096

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2537-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2525-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-01
Z-2526-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-01
Z-2527-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-01
Z-2528-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-01
Z-2529-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-01
Z-2530-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-01
Z-2531-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-01
Z-2532-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-01
Z-2533-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-01
Z-2534-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-01
Z-2535-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-01
Z-2536-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-01
Z-2537-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-01

Product code NGT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)