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Open, Classified

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

FDA Recall Z-0877-2023 · Posted 2023-01-12

Recalling FirmCovidien LP
Recall StatusOpen, Classified
Product CodeNIE
Date Initiated2022-12-07
Product Quantity359,730 (23,003 US; 336,727 OUS)

Reason for Recall

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.

Firm Action

On December 7, 2022, Medtronic began notifying customers who had received the affected products. Customers were instructed to quarantine, discontinue use, and return unused products. Customers should forward the notification to those who need to be aware within the organization, and to any location where the devices have been distributed.

Root Cause

Process design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030209MAHURKAR OPLUS CATHETER, MODEL 13.5 FRThe Kendall Company · 2003-05-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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