Recall Z-1347-2021— Cardinal Health 200, LLC

Name: FDA recall Z-1347-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-19

Class II · Completed

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2021-01-19. It names one FDA 510(k) clearance: K040196. Product: Enteral Infusion Pump. Reason: The potential for air appearing in the enteral feed pumping set tubing during set-up..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Completed
Initiated: 2021-01-19
Firm location: Waukegan, IL, 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

Enteral Infusion Pump

Reason for recall

The potential for air appearing in the enteral feed pumping set tubing during set-up.

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