PlainRecalls
FDA Devices Moderate Class II Ongoing

Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119

Reported: September 8, 2021 Initiated: May 28, 2021 #Z-2364-2021

Product Description

Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119

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).

Details

Recalling Firm
Covidien, LP
Units Affected
N/A
Distribution
Worldwide distribution.
Location
North Haven, CT

Frequently Asked Questions

What product was recalled?
Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119. Recalled by Covidien, LP. Units affected: N/A.
Why was this product recalled?
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Which agency issued this recall?
This recall was issued by the FDA Devices on September 8, 2021. Severity: Moderate. Recall number: Z-2364-2021.