Palindrome Precision RT Chronic Catheter Kit Withdrawn for Labeling Enhancements
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to implement point-of-use labeling and enhanced instructions for use. No illnesses or injuries 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: This is a FDA Class II voluntary precautionary recall. No illnesses, injuries, or documented product defect are reported. The withdrawal addresses labeling and instructional content enhancements rather than a safety-critical product defect, aligning with the Moderate severity criterion for voluntary precautionary recalls.
Plain-English summary
Covidien, LP is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits (reverse-tunneled, 15 Fr/Ch x 33 cm, Item Code 8888541033P) from worldwide distribution. The affected lot numbers are: 1727100082, 1804000124, 1908400303, 2001400121, 1730500134, 1805900129, 1926100248, 2009300116, 1732700146, 1816400078, 1926100292, 2023300132, 1734700118, 1823400098, 1931600117, 2027200192, 1801000131, and 1902800150.
The manufacturer is implementing point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). These improvements are intended to provide clearer guidance to healthcare professionals.
Patients and healthcare providers using devices from the affected lot numbers should expect to receive updated labeling and instructions. No illnesses or injuries related to this device have been reported.
The recalled product
- Product
- Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
- 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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