FDA recall Z-2376-2023

Covidien LP · Class I · device

Product

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104003HP

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

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

Key facts

Status
Ongoing
Initiation date
2023-06-28
Report date
2023-08-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2376-2023