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U.S. Department of Health and Human Services

Class 1 Device Recall hemodialysis catheter

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  Class 1 Device Recall hemodialysis catheter see related information
Date Initiated by Firm June 08, 2022
Date Posted July 07, 2022
Recall Status1 Open3, Classified
Recall Number Z-1316-2022
Recall Event ID 90311
510(K)Number K111372  
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
Product Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Code Information Code Information organized as "Model No., Serial No., GTIN": 8888119360, 1916500132, 20884521012803; 8888119364, 1831000099, 20884521056555; 8888119364, 1832300114, 20884521056555; 8888119364, 2019500276, 20884521056555; 8888119364, 2106900226, 20884521056555; 8888123404, 1912600108, 20884521056586; 8888123404, 1934400172, 20884521056586; 8888123404, 2012100136, 20884521056586; 8888123404, 2017500130, 20884521056586; 8888123404, 2034400075, 20884521056586; 8888123404, 2104600236, 20884521056586; 8888123404, 2125800094, 20884521056586; 8888123404, 2127200415, 20884521056586; 8888123410, 2019500253, 20884521012988; 8888123410, 2104100079, 20884521012988; 8888128450, 2127200431, 20884521013008; 8888128454, 2017800061, 10884521056619; 8888128454, 1822600121, 20884521056616; 8888128454, 2017800061, 20884521056616; 8888128460, 2019500266, 20884521013053; 8888145014, 1715100153, 10884521013148; 8888145014, 1715800117, 10884521013148; 8888145014, 1715900177, 10884521013148; 8888145014, 1716100154, 10884521013148; 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Recalling Firm/
Manufacturer		 Covidien Llc
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact Pamela Lee
1-303-3052701
Manufacturer Reason
for Recall		 There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
FDA Determined
Cause 2		 Process control
Action Medtronic distributed a recall notification to customers by mail on 06/08/2022. Customers were instructed to immediately quarantine and discontinue use for specific lots of chronic hemodialysis catheters, which are to be returned to Medtronic. If customers have further distributed product, they are asked to forward the information from the recall notification to those recipients. All customers are asked to complete and return the Consignee Product Retrieval Confirmation Form to rs.gmbfcamitg@medtronic.com. Additionally, consignees are asked to share the notice within their organization and retain it for their records regarding the retrieval of unused product. If a consignee is aware of any adverse events associated with recalled product, they are to submit a report to FDA via Medwatch. Customers with any questions can contact their Medtronic Representative or call Customer Service at 800-962-9888, option 2. ***Updated 8/16/22*** Medtronic has created a website to help customers identify affected product: https://www.medtronic.com/covidien/en-us/products/c/renal-care-recall-lookup-tool.html#lotLookupTool
Quantity in Commerce 576,018 units
Distribution Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Viet Nam, Virgin Islands, and Zimbabwe.
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 = MSD and Original Applicant = COVIDIEN
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