FDA Enforcement Class II Ongoing

Kangaroo 924 Safety Screw Spike Set, Product Code 775759

Recall: Z-2105-2020 · Reported June 3, 2020

Enforcement

Recall Number
Z-2105-2020
Event ID
84656
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
June 3, 2020
Initiation Date
December 26, 2019
Classification Date
May 22, 2020
Address
7000 Cardinal Pl, N/A, Dublin, OH, 43017-1091, United States

Description

Kangaroo 924 Safety Screw Spike Set, Product Code 775759

Reason

The feeding spike sets may leak at the interface of the tube and spike connector.

Code Info

All

Distribution

Worldwide distribution.

Quantity

114,731, 290 total units