| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00744-1 |
| Product Name/Description |
Neonatal Soft Single-Patient Cuff Size #3
Product number: M1870S
Lot number: 23JU
PMS number: 989803167251
UDI: 20884838008544
ARTG 356357
(Philips Electronics Australia Ltd - Cuff, blood pressure, reusable) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
21/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
The Instructions for Use (IFUs) were missing from the M1870S Neonatal Cuffs size # 3 devices supplied. An investigation determined that this was isolated to one lot of Neonatal Soft Single Patient Cuff size #3 (lot 23JU). |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to:
- Inspect stock to determine if they have the affected lot number.
- If stock is affected download and print a digital copy of the Instruction for Use (IFU) and place with the affected product. The digital IFU can be found via a link in the letter supplied to affected customers.
Philips will also provide a hard copy of IFU. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |