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.
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 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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