FDAJune 28, 2023device

MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637

Official recall recorded by the U.S. Food & Drug Administration.

The 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

What to do

FDA enforcement status: Ongoing

Brands named

covidien lpcovidien

UPCs

1088452100682920884521006826

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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