Z-2370-2021 Class II Ongoing

Recalled by Covidien, LP — North Haven, CT

Recall Details

Product Type
Devices
Report Date
September 8, 2021
Initiation Date
May 28, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P

Reason for Recall

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

Distribution Pattern

Worldwide distribution.

Code Information

Lot Numbers: 1725600117 1807300169 1904900113 2009300115 1729100070 1810400154 1909400116 2019500282 1731200151 1812900134 1920500220 2021000088 1732600132 1814300200 1926100254 2027200198 1734700110 1817100089 1930900078 2028200205 1800300131 1821300123 1930900075 2034400101 1805900127 1824700118 1930900076