Class 2 Device Recall Kangaroo Enteral Feeding Spike Sets &38; Kangaroo Connect 1000ml Bag Sets

• Date Initiated by Firm: September 22, 2020
• Create Date: November 13, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0453-2021
• Recall Event ID: 86575
• 510(K)Number: K153074
• Product Classification: Pump, infusion, enteral - Product Code LZH
• Product: Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
• Code Information: All lots of products manufactured in the below timespan: July 1, 2015 and July 20, 2019
• Recalling Firm/ Manufacturer: Cardinal Health 200, LLC; 15 Hampshire St Bldg 5; Mansfield MA 02048-1113
• 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 Product Correction Notice dated 922/20 was sent to customers. Cardinal Health had previously notified customers of a Medical Device Product Advisory in December 2019 due to the potential risk of leaks with Kangaroo enteral feeding spike sets*. The purpose of this communication is to inform you that we have updated this notification to include all unexpired lots manufactured to date, in addition, we have added two additional product codes of Kangaroo Connect 500ml and 1000ml bag sets to the product correction notice. The Product Correction Notice is for all unexpired lots of the below Kangaroo enteral feeding spike sets and all lots of Kangaroo Connect 500ml and 1000ml bag sets manufactured between July 1, 2015 and July 20, 2019. We continue to receive complaints of leaking at the interface of the tube and spike connector, in addition to complaints of leaking due to PVC tubing disconnecting from the cassette in Connect bag sets. 1) INSPECT your inventory for affected product. 2) COMMUNICATE with all personnel that utilize these feeding sets the risk of leaks at the interface of the tube and spike connector in Kangaroo enteral feeding spike sets and the risk of PVC tubing disconnecting from the cassette in Kangaroo Connect Bag Sets causing leaking. 3) INSPECT the feeding set for leaks after the pump has been primed, after the infusion has started, and throughout the infusion process. " 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
• Quantity in Commerce: 197370
• Distribution: US Nationwide 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 = COVIDIEN