Palindrome RT Chronic Catheter Kit Withdrawn for Labeling and Instructions Enhancement
Covidien voluntarily withdrew Palindrome RT Chronic Catheter Kit worldwide to implement improved point-of-use labeling and enhanced instructions for use on each device.
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 Class II medical device withdrawal with no reported illnesses or injuries. The issue involves labeling and instructional enhancements, which the rubric classifies as a voluntary precautionary recall (Moderate, score 2).
Plain-English summary
Covidien, LP is conducting a voluntary worldwide withdrawal of the Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023.
The withdrawal is being conducted to implement point-of-use labeling on each device and to provide enhancements to the Instructions for Use (IFU).
Affected units carry the following lot numbers: 1730500118, 1813600098, 1911900076, 2002900137, 1733300158, 1819000139, 1915800109, 2009300076, 1801700131, 1822600144, 1921700146, 2023300126, 1804000123, 1830300170, 1926100253, 2027200177, 1804500142, 1831600080, 1933700125, 2028200196, 1809400131, 1910200092, and 1935100121.
The recalled product
- Product
- Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
- 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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