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 28 cm, Item Code 8888541028

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: 1726500092 1806600073 1833800146 2009200089 1728600060 1815800078 1904900089 2012100138 1733300161 1816400084 1906300059 2020400105 1733700172 1826200176 1910200093 2026000059 1733700178 1826800155 1917600105 2027200241 1800300143 1828200124 1926100255 2028200207 1804000125 1831000115 1931600120 2028200207 1804500144 1832300108 2000700070

Product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
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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