Recall Z-2100-2020— Cardinal Health Inc.
Class II · Ongoing
Class II FDA medical device recall by Cardinal Health Inc., initiated 2019-12-26. It names 3 FDA 510(k) clearances: K153074, K141479, K040196. Product: Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100. Reason: The feeding spike sets may leak at the interface of the tube and spike connector..
- Recalling firm
- Cardinal Health Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-12-26
- Firm location
- Dublin, OH, United States
510(k) clearances named in this recall
3 on FDA's record- K153074 — Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
- K141479 — KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
- K040196 — KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
Reason for recall
The feeding spike sets may leak at the interface of the tube and spike connector.
Data sourced from openFDA. This site is unofficial and independent of the FDA.