PlainRecalls
FDA Devices Critical Class I Ongoing

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP

Reported: August 23, 2023 Initiated: June 28, 2023 #Z-2382-2023

Product Description

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP

Reason for Recall

Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

Details

Recalling Firm
Covidien LP
Units Affected
600 units
Distribution
US Nationwide - Worldwide Distribution Foreign: Argentina Austria Bahrain Bangladesh Belgium Brazil Brunei Darussalam Canada Cayman Islands China Costa Rica Czech Republic Denmark Dominican Republic Finland France French Polynesia Germany Greece Hungary India Iran, Islamic Republic Of Ireland Italy Kuwait Malaysia Maldives Mauritius Mexico Nepal Netherlands New Caledonia Nicaragua Norway Philippines Poland Portugal Puerto Rico Saudi Arabia Singapore Slovakia South Africa Spain Sri Lanka Sweden Switzerland Thailand Turkey United Arab Emirates United Kingdom
Location
Mansfield, MA

Frequently Asked Questions

What product was recalled? ▼
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP. Recalled by Covidien LP. Units affected: 600 units.
Why was this product recalled? ▼
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 23, 2023. Severity: Critical. Recall number: Z-2382-2023.

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