Recall Z-1634-2024— Covidien LP

Name: FDA recall Z-1634-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-15

Class II · Ongoing

Class II FDA medical device recall by Covidien LP, initiated 2024-03-15. It names one FDA 510(k) clearance: K123196. Product: 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.

Recalling firm: Covidien LP
Classification: Class II
Status: Ongoing
Initiated: 2024-03-15
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K123196 — PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATHCovidien·cleared 2013-01-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.