Recall Z-2101-2020 ยท LZH Pump, Infusion, Enteral
Cardinal Health Inc.
Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559
| Date | Dec 26, 2019 |
| Status | Open, Classified |
| Reason | The feeding spike sets may leak at the interface of the tube and spike connector. |
| Root 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 ab |
| Quantity | 114,731, 290 total units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040196 | KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS Tyco Healthcare/Kendall, May 5, 2004 |
| K141479 | KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS Covidien, Dec 23, 2014 |
| K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal Covidien, Jul 6, 2016 |