Z-1007-2018 Class II Terminated
FDA device recall Z-1007-2018 was initiated by Medtronic Minimally Invasive Therapies Group on October 14, 2017 and is designated Class II. 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 su… The recall status is terminated (terminated June 15, 2018).
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.