Recall Z-1649-2016 ยท LZH Pump, Infusion, Enteral
Medtronic
Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
| Date | Apr 1, 2016 |
| Status | Terminated |
| Reason | Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm |
| Root cause | Device Design |
| Action | Medtronic(formerly) Covidien notified accounts via Urgent Medical Device Recall letter, dated 4/1/16, that specific serial numbers with software versions 1.12 and 1.13 have a software anomaly. The firm shipped replacement units with software V 1.14. Affected devices must be returned to the firm once the replacement units have been received. A Recalled Product Return Form required to be completed and returned. Questions or concerns, contact Medtronic representative or Customer Service at (800) 882-5878. |
| Quantity | 145 units |
| Distribution | Worldwide Distribution -- USA, Australia, Canada, France, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143263 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets Covidien, May 29, 2015 |