Recall Z-2105-2020— Cardinal Health Inc.

Name: FDA recall Z-2105-2020
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: K141479. Product: 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..

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

K141479 — KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORSCovidien·cleared 2014-12-23

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 924 Safety Screw Spike Set, Product Code 775759

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.