PlainRecalls
FDA Devices Moderate Class II Ongoing

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033

Reported: September 8, 2021 Initiated: May 28, 2021 #Z-2361-2021

Product Description

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033

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).

Details

Recalling Firm
Covidien, LP
Units Affected
N/A
Distribution
Worldwide distribution.
Location
North Haven, CT

Frequently Asked Questions

What product was recalled?
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033. Recalled by Covidien, LP. Units affected: N/A.
Why was this product recalled?
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Which agency issued this recall?
This recall was issued by the FDA Devices on September 8, 2021. Severity: Moderate. Recall number: Z-2361-2021.