Recall Z-2374-2021— Covidien, LP

Name: FDA recall Z-2374-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-28

Class II · Ongoing

Class II FDA medical device recall by Covidien, LP, initiated 2021-05-28. It names one FDA 510(k) clearance: K123196. Product: Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P. Reason: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU)..

Recalling firm: Covidien, LP
Classification: Class II
Status: Ongoing
Initiated: 2021-05-28
Firm location: North Haven, CT, 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 RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P

Reason for recall

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

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