| Class 1 Device Recall Medtronic | |
Date Initiated by Firm | June 28, 2023 |
Date Posted | August 11, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2377-2023 |
Recall Event ID |
92660 |
510(K)Number | K020089 K102605 |
Product Classification |
Catheter, hemodialysis, triple lumen, non-implanted - Product Code NIE
|
Product | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray
REF: 8888104004HP |
Code Information |
GTIN: 20884521128061
LOT Numbers:
2200400292 |
Recalling Firm/ Manufacturer |
Covidien LP 15 Hampshire St Mansfield MA 02048-1113
|
For Additional Information Contact | Dori Estrella-Sands 763-505-2670 |
Manufacturer Reason for Recall | 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 Determined Cause 2 | Process control |
Action | 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 |
Quantity in Commerce | 519 units |
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
|
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. 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. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database | 510(K)s with Product Code = NIE 510(K)s with Product Code = NIE
|
|
|
|