FDA Enforcement
Class II
Ongoing
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
Recall: Z-1634-2024
·
Reported May 1, 2024
Enforcement
- Recall Number
- Z-1634-2024
- Event ID
- 94266
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Covidien LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 1, 2024
- Initiation Date
- March 15, 2024
- Classification Date
- April 24, 2024
- Address
- 15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States
Description
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
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 Info
GTIN: 20884521157733 Lot Number: 2318500118
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.
Quantity
305 units