Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling Enhancement
Covidien is voluntarily withdrawing the Palindrome RT Chronic Catheter Kit to add point-of-use labeling and enhance instructions for use. The withdrawal affects specific lot numbers 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: This voluntary withdrawal is for labeling and instruction improvements with no reported adverse events or injuries. Per the rubric's criterion for Score 2 (Moderate), this fits 'minor labeling errors' and 'voluntary precautionary recalls.'
Plain-English summary
Covidien, LP is voluntarily withdrawing the Palindrome RT Chronic Catheter Kit, Symmetrical Tip, Reverse-Tunneled (Item Code 8888541019) from distribution. The affected lot numbers are: 1733700175, 1806600076, 1828200123, 1930200088, 1800300146, 1814300196, 1828900141, 2012100137, 1805200088, 1822000084, 1829500128, and 2027200247.
The company is implementing this withdrawal to add point-of-use labeling to each device and to enhance the Instructions for Use (IFU). These improvements will help healthcare providers better understand how to use the device safely and effectively.
These catheter kits have been distributed worldwide. Healthcare facilities and providers using this device should watch for updated labeling and instructions from Covidien.
Patients and healthcare providers with questions should contact Covidien, LP for additional information about this withdrawal.
The recalled product
- Product
- Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
- Manufacturer
- Covidien, LP
- Hazard
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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