Device product
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP
Z-2379-2023
Product summary
- Firm
- Covidien LP
- Event
- Event 92660
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 7293 units
- Official record key
device-enforcement:Z-2379-2023
Official wording
Reason: 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
Code information: GTIN: 10884521128071, 20884521128078 LOT Numbers: 1926100313 1926100314 1926100315 1933000064 2034900046 2102200138 2107700127 2113300296 2119400212 2123000099 2130800131 2203300174 2230400227
Distribution pattern: 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
Derived failure modes
-
Foreign material or chemical contamination
particulate