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Recall Observatory FDA recall evidence

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.