Palindrome RT Repair Kit Voluntary Withdrawal for Labeling Enhancement
Covidien is conducting a voluntary withdrawal of Palindrome RT Repair Kit 15 FR TAL 23cm devices to implement improved point-of-use labeling and enhance the 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 voluntary withdrawal conducted to improve labeling and device instructions rather than to address a documented safety defect or patient harm. The Class II classification and the nature of the improvement indicate a precautionary action with moderate severity.
Plain-English summary
Covidien, LP is conducting a voluntary withdrawal of the Palindrome RT Repair Kit 15 FR TAL 23cm (Item Code 8888541123) to implement point-of-use labeling on each device and enhance the Instructions for Use (IFU). The enhancements are designed to improve clarity and proper use of the device.
The affected lot numbers are 1616800188, 1719300113, 1828900138, 2023300147, 1703200130, 1816400079, 1833800127, 2026000048, 1713700156, 1822000123, and 2009300120. The devices have been distributed worldwide.
Healthcare providers and patients who have received this device should contact Covidien or their healthcare provider with any questions about the withdrawal or the device's use.
The recalled product
- Product
- Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
- Manufacturer
- Covidien, LP
- Hazard
- labeling-clarity
Distribution
Distribution scope not specified by the agency.
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