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U.S. Department of Health and Human Services

Class 2 Device Recall Kangaroo Epump Safety Screw Spike with Flush Bag

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  Class 2 Device Recall Kangaroo Epump Safety Screw Spike with Flush Bag see related information
Date Initiated by Firm December 26, 2019
Create Date May 22, 2020
Recall Status1 Open3, Classified
Recall Number Z-2103-2020
Recall Event ID 84656
510(K)Number K040196  
Product Classification Pump, infusion, enteral - Product Code LZH
Product Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100
Code Information All
Recalling Firm/
Manufacturer
Cardinal Health Inc.
7000 Cardinal Pl
Dublin OH 43017-1091
Manufacturer Reason
for Recall
The feeding spike sets may leak at the interface of the tube and spike connector.
FDA Determined
Cause 2
Process control
Action A Medical Device Product Advisory letter dated 12/23/19 was sent to customers. 1) INSPECT your inventory for affected product. 2) COMMUNICATE with all personnel that utilize the equipment the risk of leaks at the interface of the tube and spike connector. 3) INSPECT the feeding set for leaks after the pump has been primed and the infusion has started. " If a leak is detected the feeding set must be discarded and a new feeding set must be obtained. Inspect the new feeding set for leaks in the same manner. 4) NOTIFY any customers to whom you may have distributed or forwarded affected product about this product advisory. 5) RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652-9648 or email to gmb-fieldcorrectiveaction@cardinalhealth.com, whether or not you have affected product. Please contact the Customer Service group for any questions related to this action: " Hospital800-964-5227 " Federal Government800-444-1166 " Distributor800-635-6021 " All other customers888-444-5440 For questions related to the notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
Quantity in Commerce 114,731, 290 total units
Distribution Worldwide distribution.
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
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