Device product
Palindrome 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
Z-1634-2024
Product summary
- Firm
- Covidien LP
- Event
- Event 94266
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 305 units
- Official record key
device-enforcement:Z-1634-2024
Official wording
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
Code information: GTIN: 20884521157733 Lot Number: 2318500118
Distribution pattern: 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.
Derived failure modes
-
Unknown
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