Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Ti...

FDA Device Recall #Z-1634-2024 — Class II — March 15, 2024

Recall Summary

Recall Number Z-1634-2024
Classification Class II — Moderate risk
Date Initiated March 15, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Covidien LP
Location Mansfield, MA
Product Type Devices
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.

Lot / Code Information

GTIN: 20884521157733 Lot Number: 2318500118

Other Recalls from Covidien LP

Recall # Classification Product Date
Z-0257-2025 Class II Chameleon PTA Balloon Catheter with Injection P... Sep 19, 2024
Z-1635-2024 Class II Palindrome Precision H Chronic Catheter Kit 1... Mar 15, 2024
Z-0845-2024 Class II Sofsilk Braided Silk sutures: CS-211 SOFSILK* ... Dec 21, 2023
Z-0844-2024 Class II Surgilon Braided Nylon sutures: 88861919-31 ... Dec 21, 2023
Z-0986-2024 Class II AbsorbaTack Absorbable Fixation Device 30 Viole... Nov 16, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.