FDAFDA · Food and drugs·Recall number Z-1007-2018
MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
Published March 21, 2018 · Recall initiated: October 14, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Medtronic Minimally Invasive Therapies Group
- Distributor
- U.S.
- Lot
- UDI: 10884521126473/20884521126470 Lot: 1717900160.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States