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 23 cm, Item Code 8888541023

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: 1730500118 1813600098 1911900076 2002900137 1733300158 1819000139 1915800109 2009300076 1801700131 1822600144 1921700146 2023300126 1804000123 1830300170 1926100253 2027200177 1804500142 1831600080 1933700125 2028200196 1809400131 1910200092 1935100121

Product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
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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