Type of Product |
Medical Device |
TGA Recall Reference |
RC-2013-RN-01288-1 |
Product Name/Description |
PLUM LifeCare 5000 Series and PLUM XL Familiy of Infusers
Plum LifeCare 5000 List Number: 02507
Plum XL List Number: 11555
Plum XLM List Number: 11846
Plum XLD List Number: 11859
ARTG Number: 138109 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
10/12/2013 |
Responsible Entity |
|
Reason/Issue |
The door roller assembly on the Plum A Lifecare 5000 Series and Plum XL has the potential to break which can lead to possible unrestricted flow and/or over delivery during the removal of the IV administration set's cassette from the pump. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Hospira is requesting hospitals to take the following steps to inspect the door assemble prior to loading the cassette: -Open the cassette door by pulling on the lever - Unlatch the cassette door by pushing on the door release tab and pulling the door down. -Visually inspect the door roller pin for any evidence of the damage or door roller misalignment. -Ensure that the door roller spins smoothly with a finger touch. If any door rollers or pins appear losse, broken or missing, Hospira is advising to remove the device from use. Hospira is in the process of retiring the Plum LifeCare 5000 and Plum XL in 2015. |
Contact Information |
1300 046 774 (Option 1) - Hospira Quality Assurance |