Palindrome RT Repair Kit Withdrawn for Labeling and Instruction Enhancements
Covidien is voluntarily withdrawing the Palindrome RT Repair Kit (Lot 1925300162) worldwide to implement improved point-of-use labeling and enhanced Instructions for Use (IFU).
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 voluntary, precautionary action focused on labeling and instructional improvements. No illnesses, injuries, or deaths have been reported. The FDA Class II classification indicates moderate patient risk, but the preventive nature of these improvements and the absence of adverse events place this in the Moderate category per the rubric.
Plain-English summary
Covidien, LP is voluntarily withdrawing the Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile (Item Code 8888541155) from worldwide distribution.
The withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). These improvements address current gaps in device labeling and user guidance.
The affected product was distributed worldwide under Lot Number 1925300162.
The recalled product
- Product
- Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
- Manufacturer
- Covidien, LP
- Category
- Medical Device — Repair Kit
- Hazard
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: 1925300162
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 18 recalled by Covidien, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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