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U.S. Department of Health and Human Services

Class 2 Device Recall Palindrome Precision HSI Chronic Catheter Sport Pack

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 Class 2 Device Recall Palindrome Precision HSI Chronic Catheter Sport Packsee related information
Date Initiated by FirmMarch 15, 2024
Date PostedApril 24, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1634-2024
Recall Event ID 94266
510(K)NumberK123196 
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
ProductPalindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888119369P
Code Information GTIN: 20884521157733 Lot Number: 2318500118
Recalling Firm/
Manufacturer		 Covidien LP
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information ContactErika 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
ActionMedtronic 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 Commerce305 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = MSD
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