Device 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
Z-1635-2024
Product summary
- Firm
- Covidien LP
- Event
- Event 94266
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 878 units
- Official record key
device-enforcement:Z-1635-2024
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: 20884521158082, 10884521158085 Lot Number: 2228000089, 2201700103, 2228000074
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