Palindrome RT Chronic Catheter Kit Labeling Enhancement Withdrawal
Covidien, LP is voluntarily withdrawing Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and Instructions for Use. No injuries or illnesses have been reported.
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: FDA Class II voluntary precautionary withdrawal for labeling and instructional improvements. No reported illnesses or injuries; the issue is limited to inadequate labeling and instructions for use.
Plain-English summary
Covidien, LP is voluntarily withdrawing Palindrome RT Chronic Catheter Kits, Symmetrical Tip, Reverse-Tunneled, 15 Fr/Ch (5.0 mm) x 33cm (Item Code 8888541033), from the market due to the need for labeling enhancements.
The company is implementing point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). This is a precautionary measure and no injuries or illnesses have been reported in connection with these devices.
The affected lot numbers are: 1800300145, 1814300204, 2009300078, 2027200251, 1805900115, 1926100256, and 2017500135. The product was distributed worldwide.
Patients and healthcare providers with affected devices should contact Covidien, LP or their medical device supplier for instructions on device replacement or return procedures. Healthcare facilities should quarantine and manage affected devices according to the company's guidance.
The recalled product
- Product
- Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
- 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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