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MAHURKAR recallZ-2386-2023 · Covidien LP · initiated Jun 28, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Covidien LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

Medtronic issued Urgent Medical Device Recall letter beginning on June 28, 2023. Letter states reason for recall, health risk and action to take: To help you identify if you have affected product, please visit our website www.Medtronic.com/Mahurkar-Triple-Lumen-Catheter-Recall. Here you will find a tool to help you determine if the product you have is affected by this recall. 2. Immediately quarantine and discontinue use of all unused Mahurkar TM Acute Triple Lumen Catheters and Mahurkar TM Acute High Pressure Triple Lumen Catheters referenced in Attachment B - List of affected Lot numbers (see Attachment A for guidance to identify impacted product). Note: This recall does not include Mahurkar Elite Catheters. 3. Complete the online Customer Confirmation Form using the link below within 3 business days of receiving this notice. Replying promptly will confirm your receipt of the notification and prevent you from receiving repeat notices. Link: https://www.novasyte.com/medtronic/fa1333 Note: Please complete the online Customer Confirmation Form even if you DO NOT have affected product. 4. If you have affected product, it must be returned for processing. Upon completion of the online Customer Confirmation Form, Customer Service will contact you with an RGA number to return all unused affected Mahurkar TM Acute Triple Lumen Catheters and Mahurkar TM Acute High Pressure Triple Lumen Catheters from your inventory to Medtronic. 5. This notice should be passed on to all those who need to be aware within your organization or to any organization including but not limited to Nephrologists, Intensivists, physicians, renal nurses, critical care nurses, or other dialysis staff where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. Medtronic has partnered with Novasyte, an IQVIA company, to assist in this recall. For assistance regarding online response processing or product return for this recall, please contact Novas

Recall details

Recall number
Z-2386-2023
Status
Open, Classified
Initiated by the company
Jun 28, 2023
Posted by the FDA
Aug 11, 2023
Recalling firm
Covidien LP
Quantity
69987 units
Product code
NIE
FDA submissions
K020089, K102605
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 Philippines Poland Portugal Puerto Rico Saudi Arabia Singapore Slovakia South Africa Spain Sri Lanka Sweden Switzerland Thailand Turkey United Arab Emirates United Kingdom

Product description

MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

GTIN:10884521006782 / 20884521006789 LOT Numbers: Lot Number 1907700087 1915800147 1915800149 1924500084 1924500085 1924500087 1924500088 1933000070 1933000071 1933000073 1934300131 1934300134 1934300135 1934300136 1934400128 1934400174 1935100073 1935100074 1935100085 1935100086 1935100087 1935100088 2000700065 2000700066 2002100112 2002100114 2002900106 2003900122 2003900123 2005500062 2005500064 2006500075 2007800071 2007800072 2007800073 2009200094 2009300094 2009300095 2009300096 2010800205 2011300096 2011300098 2011300099 2017400084 2018800018 2018800021 2018800023 2019500195 2019500198 2029700145 2032300067 2032800039 2032800040 2033100068 2033100069 2104100115 2122900118 2122900159 2122900161 2122900195 2122900217 2122900276 2122900277 2123000092 2123000115 2124600186 2124600190 2127300095 2131200168 2131200172 2131200175 2131200178 2131200179 2133700137 2133700138 2133700140 2230400265 2230400277 2230400278 2234800082

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

23 devices cleared under K020089, K102605 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92660).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page