Palindrome Precision RT Chronic Catheter Kit recalled for labeling and instruction updates
Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to add point-of-use labeling and improve Instructions for Use. No adverse events 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: This is a Class II recall conducted as a voluntary, precautionary withdrawal to improve labeling and instructions for use. No illnesses, injuries, or adverse events have been reported, consistent with routine labeling and documentation enhancements.
Plain-English summary
Covidien, LP is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit (Item Code 8888541019P). This medical device is used for vascular access and features a symmetrical tip with reverse-tunneled design, measuring 15 Fr/Ch (5.0 mm) x 19 cm.
The withdrawal is being conducted to implement point-of-use labeling on each device and to provide enhancements to the Instructions for Use. No adverse events or illnesses have been reported in connection with this device.
The device has been distributed worldwide, with multiple lot numbers included in this recall.
The recalled product
- Product
- Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
- Manufacturer
- Covidien, LP
- Category
- Medical Device — Vascular Access
Distribution
Distribution scope not specified by the agency.
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