FDA recall Z-2375-2021

Product

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

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-2375-2021