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U.S. Department of Health and Human Services

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

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 Class 2 Device Recall Kangaroo ePump Enteral Feeding Pump and Enteral Feeding Setssee related information
Date Initiated by FirmJanuary 19, 2021
Create DateApril 02, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1347-2021
Recall Event ID 87281
510(K)NumberK040196 
Product Classification Pump, infusion, enteral - Product Code LZH
ProductEnteral 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 2
Process control
ActionOn 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 Commerce146,944,334 units
DistributionDomestic: 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 CycleTPLC 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) Database510(K)s with Product Code = LZH
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