| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00976-1 |
| Product Name/Description |
Kangaroo Enteral Feeding Pump Sets
Kangaroo Joey Pump Set 1000 mL
Product Code: 666106-
Kangaroo Joey ENPlus Spike Set
Product Code: 777501
Kangaroo Joey ENPlus 3-in-1 Set
Product code: 777503
Kangaroo Pump Set 1000 mL EZ Bag
Product code: 777106
All product manufactured from April 2022 with lot numbers 22D to July 2023 to lot numbers 23G
ARTG 189723 & 185653 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
The issue relates to potential air entry into the feed set tubing, which appears as air space in the tubing. It is not uncommon, and not a problem, to see a small amount of air in the feed tubing (approximately 1.3 cm) after the pump checks for any blockages.
Do not use the feeding set if you see a single segment of air measuring greater than 2.5 cm.
Air entry into the feed set tubing may potentially result in the following health consequences: vomiting, dehydration, hypoglycaemia, abdominal pain, and abdominal distention in patients. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to check the feed set for entry of air in the tubing by following the steps below (included as an addendum in the customer letter):
- Press “Run” on the pump after installing and priming the feeding set.
- After 30 seconds, observe the tubing between the pump and the patient to check for air being drawn into the line.
- It is not uncommon, and not a problem, to see a small amount of air in the feed tubing (approximately 1.3 cm [1/2 inch]) after the pump checks for any blockages.
- Do not use the feeding set if you see a single segment of air measuring greater than 2.5 cm (1 inch).
- Do not use the feeding set if you see several air bubbles that cumulatively measure greater than 2.5 cm (1 inch).
Customers are to place the customer letter and addendum with affected product. |
| Contact Information |
0437 123 118 - Vinh Dinh, Cardinal Health |