Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
- Company
- Cardinal Health Inc.
- Recall Initiated
- December 26, 2019
- Recall Number
- Z-2102-2020
- Quantity
- 114,731, 290 total units
- Firm Location
- Dublin, OH
Reason for Recall
The feeding spike sets may leak at the interface of the tube and spike connector.
Distribution
Worldwide distribution.
Lot / Code Info
All
Root Cause
Process control
Action Taken
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.