Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2379-2023 — MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP

U.S. FDA — Device Enforcement · United States · 2023-06-28 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2379-2023
Date of alert
2023-06-28
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Covidien LP
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10884521128071
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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