Recall Z-2102-2020— Cardinal Health Inc.

Name: FDA recall Z-2102-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-26

Class II · Ongoing

Class II FDA medical device recall by Cardinal Health Inc., initiated 2019-12-26. It names one FDA 510(k) clearance: K153074. Product: Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD. Reason: The feeding spike sets may leak at the interface of the tube and spike connector..

Recalling firm: Cardinal Health Inc.
Classification: Class II
Status: Ongoing
Initiated: 2019-12-26
Firm location: Dublin, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K153074 — Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect PortalCovidien·cleared 2016-07-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.