Palindrome Precision RT Chronic Catheter Kits Withdrawn for Labeling and Instruction Updates
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance device instructions for proper 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 voluntary precautionary recall conducted to implement labeling improvements and instruction enhancements. No hazard is specified in the source text, no injuries or illnesses are reported, and the FDA classification is Class II, which meets the rubric criterion for Moderate severity (Score 2).
Plain-English summary
Covidien, LP is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits (Symmetrical Tip, Reverse-Tunneled, 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P) from worldwide distribution. The withdrawal affects 32 specific lot numbers.
The voluntary withdrawal is being conducted to implement point-of-use labeling on each device and to enhance the Instructions for Use (IFU).
Healthcare facilities and patients using this device should contact Covidien for information about the withdrawal and available options or replacements.
The recalled product
- Product
- Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
- Manufacturer
- Covidien, LP
- Hazard
- labeling-deficiency
- instructions-deficiency
Distribution
Distribution scope not specified by the agency.
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