Covidien LP: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888345611HP

Hazard

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 from the source

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: 32125 units Lot/code info: GTIN: 10884521128149 / 20884521128146 LOT Numbers: 1908400297 1908400298 1908400299 1908800136 1920500260 1924500090 1926100317 1926100318 1926800467 2018800025 2018800044 2018800045 2018800046 2019500187 2020500079 2021000109 2021000110 2021000111 2023400151 2102200137 2102600093 2104100085 2113000069 2113300288 2116200130 2116500175 2119400217 2119400219 2131200183 2203300166 2203300169 2203300170 2203300173 2203300175 2232700163 2232700197 2232700207 2234800070

UPC codes

10884521128149, 20884521128146

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.