Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling and Instruction Updates
Covidien, LP is voluntarily withdrawing specific lots of the Palindrome RT Chronic Catheter Kit to implement point-of-use labeling and enhance the Instructions for Use.
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 implement labeling and instruction enhancements. No safety defect, injury, or illness is reported. The action addresses documentation and labeling only.
Plain-English summary
Covidien, LP is voluntarily withdrawing specific lots of the Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled (15 Fr/Ch, 5.0 mm diameter, 55 cm length) from worldwide distribution. The affected lot numbers are: 1725600159, 1831000117, 1906000012, 1910600263, 1732700137, 1902800146, 1908400348, and 2009300117.
The withdrawal is being conducted to implement point-of-use labeling on each device and to enhance the Instructions for Use. No injuries or illnesses have been reported.
Patients currently using the affected catheter kits should consult with their healthcare provider regarding the withdrawal and any appropriate next steps for their treatment. Healthcare providers should contact the manufacturer for information on replacement devices and alternatives.
The recalled product
- Product
- Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
- 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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