Palindrome Precision RT Catheter Kit Withdrawn for Labeling and Instruction Enhancements
Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to implement point-of-use labeling and enhanced instructions for use on all affected units.
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 focused solely on labeling and instruction improvements with no reported adverse events or hazards described in the source. Per the rubric, voluntary recalls are classified as Score 2 (Moderate).
Plain-English summary
The Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled (15 Fr/Ch, 5.0 mm x 23 cm, Item Code 8888541023P), manufactured by Covidien, LP, is the subject of a voluntary withdrawal.
The manufacturer is conducting this withdrawal to implement point-of-use labeling on each device and to enhance the Instructions for Use (IFU) provided with the product.
This voluntary withdrawal affects units that have been distributed worldwide. The withdrawal applies to units identified by specific lot numbers including 1724200116, 1815000199, 1921300032, 1932300191, 1725600107, 1815800076, 1921300034, 1932300192, 1727100076, 1817100090, and others as provided to the FDA.
Healthcare facilities and other recipients of affected units should contact Covidien, LP for information regarding the withdrawal and available options for replacement or remediation.
The recalled product
- Product
- Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
- Manufacturer
- Covidien, LP
- Hazard
- inadequate-labeling
- inadequate-instructions
Distribution
Distribution scope not specified by the agency.
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