The Recall Desk
LowFDA (Devices)·Z-2375-2021·Announced 2021-09-08

Covidien Palindrome Chronic Catheter Kits Withdrawn to Enhance Labeling and Instructions

Covidien, LP is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to improve point-of-use labeling and instructions for use. The withdrawal affects devices distributed worldwide.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is a voluntary withdrawal to enhance labeling and instructions for use, with no reported safety hazard or adverse events. Per the severity rubric, documentation issues without reported incidents are classified as Low severity.

Plain-English summary

Covidien, LP is conducting a voluntary withdrawal of Palindrome Precision RT Chronic Catheter Kit devices (Item Code 8888541055P, 15 Fr/Ch (5.0 mm) x 55 cm).

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

The devices have been distributed worldwide. The withdrawal includes 16 specific lot numbers: 1726300131, 1805900130, 1911900083, 2019900069, 1731900198, 1813600105, 1926100249, 2023300142, 1800300137, 1827600140, 1926100293, 2023300118, 1802400067, 1835100109, 2002100137, and 2034400093.

The recalled product

Product
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
Manufacturer
Covidien, LP
Hazard
  • labeling

Distribution

Distribution scope not specified by the agency.