FDA recall Z-2363-2021

Covidien, LP · Class II · device

Product

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055

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

Worldwide distribution.

Key facts

Status
Ongoing
Initiation date
2021-05-28
Report date
2021-09-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Haven, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2363-2021