Palindrome RT Repair Kit voluntary withdrawal for labeling enhancements
Covidien, LP is voluntarily withdrawing the Palindrome RT Repair Kit to implement improved point-of-use labeling and enhance the Instructions for Use. This affects Item Code 8888541133 (Lot Number 1705400292) distributed worldwide.
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: Class II medical device withdrawal conducted voluntarily by the manufacturer for labeling and instruction improvements. This matches the rubric classification for Score 2 (Moderate) as a voluntary precautionary recall.
Plain-English summary
Covidien, LP is voluntarily withdrawing the Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile (Item Code 8888541133) from worldwide distribution. The withdrawal affects Lot Number 1705400292.
The manufacturer is implementing point-of-use labeling on each device and enhancing the Instructions for Use (IFU). The withdrawal is voluntary, initiated by the manufacturer.
The recalled product
- Product
- Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
- Manufacturer
- Covidien, LP
- 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: 1705400292
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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