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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 33 cm, Item Code 8888541033P

Covidien, LP Recall 88250 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2373-2021
Event ID88250
Event DescriptionPalindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
Product TypeDevices
DistributionWorldwide distribution.
QuantityN/A
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: 1727100082 1804000124 1908400303 2001400121 1730500134 1805900129 1926100248 2009300116 1732700146 1816400078 1926100292 2023300132 1734700118 1823400098 1931600117 2027200192 1801000131 1902800150
Center Classification Date20210827
Recall Initiation Date20210528
Recalling FirmCovidien, LP
Initial Notification Letter
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