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Critical recall: Death or serious injury has been reported or is considered likely. Stop using this product now.

Covidien LP 2023-08-23 Health critical FDA
Health · FDA · Recall #FDA-Z-2391-2023

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved… Recall

Issued August 23, 2023 · Covidien LP

In August 2023, Covidien LP recalled the MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

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 you should do

  1. 1 Stop using MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Covidien LP to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Covidien LP
Category
Health
Recall date
August 23, 2023
Units affected
Not reported
Sold at
US Nationwide - Worldwide Distribution Foreign: Argentina Austria Bahrain Bangladesh Belgium Brazil Brunei Darussalam Canada Cayman Island
Recall number
FDA-Z-2391-2023
Made in
United States
Issuing agency
FDA

In context

  • Covidien LP has 6 recalls in our database, including 4 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 903rd Health recall we've logged in 2023.
Read the official FDA notice

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