| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00412-1 |
| Product Name/Description |
Centrella and Pro+ Mattress Replacement System (MRS)
Multiple Product codes, Serial Numbers and Product Descriptions
ARTG 312121, 382825 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
The top cover of affected mattresses may delaminate. Contributing causes of delamination include improper cleaning of the product (i.e., excessive use of cleaning agents containing bleach) and a lack of adequate details on the appropriate use of cleaning agents containing bleach in the product Instructions for Use (IFU).
Update 12/07/2024:
Baxter has issued a follow up communication informing customers that the Centrella max and pro+ Instructions for Use (IFU) has been updated to include additional instructions and warnings regarding the use of cleaning agents that include bleach. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Update 12/07/2024:
Customers can obtain the updated IFU from:
· The Centrella max IFU can be accessed at https://www.hillrom.com/en/products/centrella-smart-bed/ then go to “Education and Documentation” and then “User Manual”.
· The pro+ IFU can be accessed at https://www.hillrom.com/en/products/pro-plus-surface/ then go to “Education and Documentation” and then “Instructions for Use”.
· The last order date for replacement top covers, components, and surfaces due to delamination is the 30th of November 2024.
· If replacements need to be ordered customers are to contact Baxter Healthcare Technical Services between the hours of 8:00 am and 5:00 pm, Monday to Friday. |
| Contact Information |
1800 445 576 - Baxter Technical Services |