Class 2 Device Recall Kangaroo Joey Safety Screw Spike Set

• Date Initiated by Firm: December 26, 2019
• Create Date: May 22, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2101-2020
• Recall Event ID: 84656
• 510(K)Number: K040196 K141479 K153074
• Product Classification: Pump, infusion, enteral - Product Code LZH
• Product: Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559
• 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: 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; 510(K)s with Product Code = LZH