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 19 cm, Item Code 8888541019

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: 1733700175 1806600076 1828200123 1930200088 1800300146 1814300196 1828900141 2012100137 1805200088 1822000084 1829500128 2027200247

Product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
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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