Z-1635-2024 Class II Ongoing
FDA device recall Z-1635-2024 was initiated by Covidien LP on Mar 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: 878 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2024
- Initiation Date
- Mar 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 878 units
Product Description
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
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: 20884521158082, 10884521158085 Lot Number: 2228000089, 2201700103, 2228000074
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1635-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026