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Recall Observatory FDA recall evidence

Device product

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023

Z-2359-2021

May 28, 2021

Class II

Product summary

Firm
Covidien, LP
Event
Event 88250
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2359-2021

Official wording

Reason: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

Code information: Lot Numbers: 1730500118 1813600098 1911900076 2002900137 1733300158 1819000139 1915800109 2009300076 1801700131 1822600144 1921700146 2023300126 1804000123 1830300170 1926100253 2027200177 1804500142 1831600080 1933700125 2028200196 1809400131 1910200092 1935100121

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).