MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No. 8888135131; 13.5 cm, Curved Extensions, Kit - Model No. 8888135132; 13.5cm, Pre-Curved, Kit - Model No. 8888135133; 13.5cm, Straight Extensions, IC Tray, Model No. 8888135134; 16cm, Straight Extensions, Kit - Model No. 8888135161; 16cm, Curved Extensions, Kit - Model No. 8888135162; 16 cm, Pre-Curved, Kit - Model No. 8888135163; 16cm, Straight Extensions, IC Tray - Model No. 8888135164; 19.5cm, Straight Extensions, Kit - Model No. 8888135191; 19.5cm, Curved Extensions, Kit - Model No. 8888135192; 19.5cm, Pre-Curved, Kit - Model No. 8888135193; 19.5cm, Straight Extensions, IC Tray - Model No. 8888135194; 19.5cm, Curved Extensions, PASS Tray - Model No. 8888135198; 24cm, Straight Extensions, Kit - Model No. 8888135241; 24cm, Curved Extensions, Kit - Model No. 8888135242; 24cm, Pre-Curved, Kit - Model No. 888813524
There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
Worldwide distribution. US nationwide including Guam, USVI, and Puerto Rico; Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, Italy, Jamaica, Kenya, Malaysia, Malta, Mauritius, Mexico, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Uganda, United Arab Emirates, and United Kingdom.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0877-2023