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U.S. Department of Health and Human Services

Class 2 Device Recall Palindrome Precision H Chronic Catheter Kit

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  Class 2 Device Recall Palindrome Precision H Chronic Catheter Kit see related information
Date Initiated by Firm March 15, 2024
Date Posted April 24, 2024
Recall Status1 Open3, Classified
Recall Number Z-1635-2024
Recall Event ID 94266
510(K)Number K123196  
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
Product Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion.
Model Number (CFN): 8888145044CP
Code Information GTIN: 20884521158082, 10884521158085 Lot Number: 2228000089, 2201700103, 2228000074
Recalling Firm/
Manufacturer		 Covidien LP
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact Erika Winkels 
508-526-8478
Manufacturer Reason
for Recall		 Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
FDA Determined
Cause 2		 Process control
Action Medtronic issued Urgent Medical Device Recall Letter on 3/15/24. Letter states reason for recall, health risk and action to take: 1.Immediately quarantine and discontinue use of unused affected product (see Attachment A). 2. Return all unused products from your inventory to Medtronic. Please contact: rs.covidienfeedbackcustomerservice@medtronic.com for the Return Good Authorization (RGA). a.Credit for the returned affected product will be issued based on the RGA number. b. If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor. 3. In addition, please complete and return the enclosed Customer Confirmation Form to rs.gmbmitgfca@medtronic.com even if you do not have unused inventory. 4. This notice should be passed on to those who need to be aware within your organization or to any organization including, but not limited to, nephrologists, intensivists, implanting and managing 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. If you have questions regarding this communication, please contact your local representative or Customer Service at 800-962-9888, option 2 (Monday Friday 8:00 a.m. to 6:30 p.m.).
Quantity in Commerce 878 units
Distribution Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Denmark, Faroe Islands, France, Germany, Greece, Iceland, Ireland, Italy, Mayotte, Norway, Poland, Reunion, South Africa, Spain, Sweden, 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 = MSD and Original Applicant = COVIDIEN
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