Skip to content

MAHURKAR Elite recallZ-1007-2018 · Medtronic Minimally Invasive Therapies Group · initiated Oct 14, 2017

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Minimally Invasive Therapies Group or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1007-2018
Status
Terminated
Initiated by the company
Oct 14, 2017
Recalling firm
Medtronic Minimally Invasive Therapies Group
Product code
MPB
FDA submissions
K120674
Distribution
U.S.

Product description

MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.

Code information (models, lots, serial numbers)

UDI: 10884521126473/20884521126470 Lot: 1717900160.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

63 devices cleared under K120674 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page