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
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 Philippin Quantity: 2685 units Lot/code info: GTIN: 20884521128139 LOT Numbers: 2017400081 2028300087 2113300282 2133700046 2227800105
20884521128139
Official record: FDA (Device enforcement) ↗
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