Palindrome RT Repair Kit Withdrawn for Enhanced Labeling and Instructions
Covidien is voluntarily withdrawing the Palindrome RT Repair Kit 15 FR TAL 28cm to improve point-of-use labeling and Instructions for Use. No illnesses or injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 medical device subject to a voluntary withdrawal for labeling and instruction enhancements. No illnesses or injuries have been reported. Per the severity rubric, voluntary precautionary recalls are classified as Moderate.
Plain-English summary
The Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile (Item Code 8888541128), manufactured by Covidien, LP, is being voluntarily withdrawn from distribution.
The withdrawal is being conducted to implement point-of-use labeling on each device and to provide enhancements to the Instructions for Use. No illnesses or injuries have been reported.
The affected device was distributed worldwide. Affected lot numbers include 1834500202, 1920500219, 2014900143, 2020400107, 1914800210, 2009300121, 2017500133, and 2023300110.
The recalled product
- Product
- Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
- Manufacturer
- Covidien, LP
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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