FDAClass IISeptember 8, 2021

Palindrome RT Repair Kit 15 FR TAL 28cm recall: Labeling Error

Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128

Why was Palindrome RT Repair Kit 15 FR TAL 28cm recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 1834500202 1920500219 2014900143 2020400107 1914800210 2009300121 2017500133 2023300110

Product
Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
Recalling firm
Covidien, LP
Quantity
N/A
Distribution
Worldwide distribution.
Recall date
September 8, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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