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Covidien, LP Recall 88250

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

Covidien, LP Recall 88250 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2371-2021
Event ID88250
Event DescriptionPalindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
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: 1724200116 1815000199 1921300032 1932300191 1725600107 1815800076 1921300034 1932300192 1727100076 1817100090 1927500067 2023300141 1728600062 1817700206 1929400086 2027200174 1734700104 1826800141 1929500067 2026000073 1801000128 1831600197 1929500068 2028200214 1802400119 1833100112 1929500071 2028200215 1804000126 1905600140 1929500088 2033100065 1805200078 1906000165 1929500089 2032800041 1806600074 1908400286 1929500072 2034400102 1807300167 1906700185 1930900073 1808600066 1920500223 1930900074
Center Classification Date20210827
Recall Initiation Date20210528
Recalling FirmCovidien, LP
Initial Notification Letter
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