Recall Z-2103-2020— Cardinal Health Inc.

Name: FDA recall Z-2103-2020
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: K040196. Product: Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100. 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

K040196 — KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETSTyco Healthcare/Kendall·cleared 2004-05-05

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 Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100

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.