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.
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: 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
- labeling-issue
Distribution
Distribution scope not specified by the agency.
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