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Covidien, LP Recall 88250

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

Covidien, LP Recall 88250 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2359-2021
Event ID88250
Event DescriptionPalindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
Product TypeDevices
DistributionWorldwide distribution.
Recall ReasonThis voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Device Classification20210908
Device Code InfoLot Numbers: 1730500118 1813600098 1911900076 2002900137 1733300158 1819000139 1915800109 2009300076 1801700131 1822600144 1921700146 2023300126 1804000123 1830300170 1926100253 2027200177 1804500142 1831600080 1933700125 2028200196 1809400131 1910200092 1935100121
Center Classification Date20210827
Recall Initiation Date20210528
Recalling FirmCovidien, LP
Initial Notification Letter
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