The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. For assistance regarding online response processing or product return for this recall, please contact Novasġ A record in this database is created when a firm initiates a correction or removal action. Medtronic has partnered with Novasyte, an IQVIA company, to assist in this recall. Please maintain a copy of this notice in your records. 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. 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.ĥ. If you have affected product, it must be returned for processing. Note: Please complete the online Customer Confirmation Form even if you DO NOT have affected product.Ĥ. Replying promptly will confirm your receipt of the notification and prevent you from receiving repeat notices. Complete the online Customer Confirmation Form using the link below within 3 business days of receiving this notice. Note: This recall does not include Mahurkar Elite Catheters.ģ. 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). To help you identify if you have affected product, please visit our website Here you will find a tool to help you determine if the product you have is affected by this recall. Letter states reason for recall, health risk and action to take: Medtronic issued Urgent Medical Device Recall letter beginning on June 28, 2023. 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 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, KitĬatheter 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. Catheter, hemodialysis, triple lumen, non-implanted - Product Code NIE
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