| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00855-1 |
| Product Name/Description |
Dispenser Pump DP30
Serial numbers: 1566U2002R, 1711U1612R, 1721U1612R, 17136U2102R
UDI-DI Number: ENOU4180230ANG0
ARTG 200778
(Medical Specialties Australasia Pty Ltd - Infusion pump, general-purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
An adjustment to the intended use of the Instructions for Use (IFU) was made following an update to the clinical evaluation (technical file), due to a lack of evidence of possible use in underage patients. Additional specifications were also added to the IFU regarding tumescent anaesthesia infiltration parameters.
The changes are not because of any reported safety related incidents that have resulted in patient or user harm.
These affected serial numbers were distributed between 2018 and 2021. No other products distributed by Medical Specialties Australasia are affected. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to review the updated IFU (provided with the customer letter) which includes use on adult patients only and additional specifications including the tumescent anaesthesia infiltration parameters.
Any previous (obsolete) copies of IFU should be disposed of to prevent confusion and replaced with the updated version. |
| Contact Information |
techserv@msa.com.au - Medical Specialties Australasia Pty Ltd |