FDAClass IISeptember 8, 2021

Palindrome RT Chronic Catheter Kit Symmetrical Tip recall: Labeling Error

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033

Why was Palindrome RT Chronic Catheter Kit Symmetrical Tip 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: 1800300145 1814300204 2009300078 2027200251 1805900115 1926100256 2017500135

Product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
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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