Recall Z-1635-2024 ยท MSD Catheter, Hemodialysis, Implanted
Covidien LP
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
| Date | Apr 24, 2024 (initiated Mar 15, 2024) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | 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 d |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123196 | PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH Covidien, Jan 31, 2013 |