Palindrome RT Chronic Catheter Kit Withdrawn for Labeling and Instructions Enhancement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.
What this means for you
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
- Hazard
- mis-labeling
- instruction-deficiency
Distribution
Distribution scope not specified by the agency.
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