Covidien Palindrome Chronic Catheter Kits Withdrawn to Enhance Labeling and Instructions
Covidien, LP is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to improve point-of-use labeling and instructions for use. The withdrawal affects devices distributed worldwide.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a voluntary withdrawal to enhance labeling and instructions for use, with no reported safety hazard or adverse events. Per the severity rubric, documentation issues without reported incidents are classified as Low severity.
Plain-English summary
Covidien, LP is conducting a voluntary withdrawal of Palindrome Precision RT Chronic Catheter Kit devices (Item Code 8888541055P, 15 Fr/Ch (5.0 mm) x 55 cm).
The withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
The devices have been distributed worldwide. The withdrawal includes 16 specific lot numbers: 1726300131, 1805900130, 1911900083, 2019900069, 1731900198, 1813600105, 1926100249, 2023300142, 1800300137, 1827600140, 1926100293, 2023300118, 1802400067, 1835100109, 2002100137, and 2034400093.
The recalled product
- Product
- Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
- 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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