Device product

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

Z-1007-2018

October 14, 2017

Class II

Product summary

Firm: Medtronic Minimally Invasive Therapies Group
Event: Event 79319
Status: Terminated
Classification: Class II
Quantity: Unavailable
Official record key: device-enforcement:Z-1007-2018

Official wording

Reason: 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.

Code information: UDI: 10884521126473/20884521126470 Lot: 1717900160.

Distribution pattern: U.S.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.