Z-1007-2018Class II

MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product...

Name: Z-1007-2018 MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product...
Creator: Medtronic Minimally Invasive Therapies Group
Published: 2017-10-14
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-10-14 / Terminated / root cause: manufacturing process

FDA source

Medtronic Minimally Invasive Therapies Group began a recall of MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316 on 2017-10-14. FDA classified it as Class II and gives the reason as "Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays, Lot 1717900160, following notification from our supplier that one...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1007-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-14
Posted: 2018-03-14
Terminated: 2018-06-15
Recalling firm: Medtronic, Inc.
Product: MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
Product code: MPB Catheter, Hemodialysis, Non-Implanted
Reason for recall: Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays, Lot 1717900160, following notification from our supplier that one production lot of MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays was inadvertently shipped to Medtronic and distributed without being sterilized.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic began notifying customers via telephone on October 14, 2017, and all consignees were notified via Federal Express or certified mail on October 17, 2017. The letter informs customers that they were shipped devices that were not sterile. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice.
Distribution: U.S.
Product codes and lots: UDI: 10884521126473/20884521126470 Lot: 1717900160.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1007-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1007-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14

Product code MPB

K120674Class IIMahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen CatheterCovidien / cleared 2012-04-04

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)