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Z-1007-2018 Class II Terminated

Recalled by Medtronic Minimally Invasive Therapies Group — Mansfield, MA

Recall Details

Product Type: Devices
Report Date: March 21, 2018
Initiation Date: October 14, 2017
Termination Date: June 15, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity

Product Description

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

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.

Distribution Pattern

U.S.

Code Information

UDI: 10884521126473/20884521126470 Lot: 1717900160.