Palindrome RT Chronic Catheter Kit withdrawn for labeling and instruction improvements
Covidien is voluntarily withdrawing Palindrome RT Chronic Catheter Kit devices worldwide to implement point-of-use labeling and enhanced 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 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 voluntary precautionary withdrawal for labeling and instruction improvements with no reported illnesses or injuries, fitting the FDA Class II voluntary precautionary recall category.
Plain-English summary
Covidien, LP is conducting a voluntary worldwide withdrawal of Palindrome RT Chronic Catheter Kit devices (Symmetrical Tip, Reverse-Tunneled, 15 Fr/Ch x 28 cm, Item Code 8888541028). The withdrawal affects devices with specific lot numbers identified by the manufacturer.
The withdrawal is being conducted to implement point-of-use labeling on each device and to provide enhancements to the Instructions for Use (IFU).
This worldwide withdrawal affects healthcare facilities, providers, and patients currently using or who may receive this catheter kit. Healthcare institutions should identify affected devices using the Item Code 8888541028 and verify lot numbers against the manufacturer's list.
Healthcare providers should contact Covidien for information regarding availability of updated devices. Patients currently using this catheter should consult with their healthcare provider regarding their device and potential replacement options.
The recalled product
- Product
- Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
- Manufacturer
- Covidien, LP
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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