Covidien LP recalls MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensi

Recalled January 18, 2023 · FDA recall Z-0877-2023 · Covidien

Hazard

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. · FDA Class I

Units

359,730 (23,003 US; 336,727 OUS)

Sold at

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.

Description

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.

Product

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. 8888135243

Manufacturer(s)

Covidien LP

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →