Z-1634-2024 Class II Ongoing
FDA device recall Z-1634-2024 was initiated by Covidien LP on March 15, 2024 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 305 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2024
- Initiation Date
- March 15, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 305 units
Product 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 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
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.
Code Information
GTIN: 20884521157733 Lot Number: 2318500118