Recall Z-2368-2021— Covidien, LP

Name: FDA recall Z-2368-2021
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: K111817. Product: Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144. 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

K111817 — PALINDROME RT CHRONIC CATHETERCovidien·cleared 2011-08-30

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 RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144

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.