Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling Enhancement
Covidien is voluntarily withdrawing specific lots of Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and enhancements to device 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 medical device subject to a voluntary precautionary withdrawal for labeling and instruction enhancements. No illnesses, injuries, or actual hazards are reported in the source; the action is purely preventive and administrative.
Plain-English summary
Covidien, LP is conducting a voluntary worldwide withdrawal of specific lots of the Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm (Item Code 8888541044). The affected lot numbers are 1815000193, 1920500218, 2014900146, 2012100124, and 1905600053.
The withdrawal is being conducted to implement point-of-use labeling on each device and to provide enhancements to the device's Instructions for Use (IFU). This is a preventive action by the manufacturer.
The recalled product
- Product
- Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044
- Manufacturer
- Covidien, LP
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: 1815000193 1920500218 2014900146 2012100124 1905600053
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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