Class 2 Device Recall Kangaroo ePump Enteral Feeding Pump and Enteral Feeding Sets

• Date Initiated by Firm: January 19, 2021
• Create Date: April 02, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1347-2021
• Recall Event ID: 87281
• 510(K)Number: K040196
• Product Classification: Pump, infusion, enteral - Product Code LZH
• Product: Enteral Infusion Pump
• Code Information: Catalog Number: 612054, 613650, 614650, 672055, 673656, 673662, 674655, 674668, 674669, 716154, 762055, 763656, 763662, 765100, 765559, 772055, 773656, 773662, 775100, 775659, 776150
• Recalling Firm/ Manufacturer: Cardinal Health 200, LLC; 3651 Birchwood Dr; Waukegan IL 60085-8337
• Manufacturer Reason for Recall: The potential for air appearing in the enteral feed pumping set tubing during set-up.
• FDA Determined Cause: Process control
• Action: On 03/01/2021, Cardinal Health issued an Urgent Medical Device Correction notice to customers via letter to the potential of air entering the feed set tubing of enteral fusion pumps with the specified product codes
• Quantity in Commerce: 146,944,334 units
• Distribution: Domestic: All 50 states and DC, Foreign: Argentina, Australia, Brazil, Canada, Chile, Colombia, Japan, Mexico, Netherlands, Panama, Peru, Puerto Rico, Singapore, Switzerland, Turkey
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LZH and Original Applicant = TYCO HEALTHCARE/KENDALL