The Recall Desk
ModerateFDA (Devices)·Z-2368-2021·Announced 2021-09-08

Palindrome RT Repair Kit Withdrawn for Labeling and Instructions Enhancements

Covidien, LP is voluntarily withdrawing Palindrome RT Repair Kit 15 FR to implement point-of-use labeling and enhance Instructions for Use.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II FDA medical device recall conducted on a voluntary basis by the manufacturer. The withdrawal is to implement point-of-use labeling and enhance the Instructions for Use, indicating an administrative/preventive measure rather than a response to a reported safety incident. No safety incidents, injuries, or product defects are described in the source document.

Plain-English summary

Covidien, LP is conducting a voluntary withdrawal of the Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile (Item Code 8888541144). The affected lot numbers are 1704700210, 1822600138, and 1826200177.

The withdrawal is being conducted to implement point-of-use labeling on each device and to enhance the Instructions for Use (IFU). This is a Class II medical device classified by the FDA.

The device has been distributed worldwide. The manufacturer is voluntarily withdrawing the product as a precautionary administrative measure.

The recalled product

Product
Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
Manufacturer
Covidien, LP
Category
Medical Device
Hazard
  • labeling-deficiency

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers: 1704700210 1822600138 1826200177

Distribution

Distribution scope not specified by the agency.

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