| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00815-1 |
| Product Name/Description |
da Vinci Xi/X Instrument Arm Drapes
Lot numbers: DM3223602
Part number: 470015-07
ARTG 229102
(Device Technologies Australia Pty Ltd - Instrument/equipment drape, single-use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/09/2023 |
| Responsible Entity |
|
| Reason/Issue |
Device Technologies Australia Pty Ltd is informing that a specific lot (DM3223602) of da Vinci Xi/X Instrument Arm Drapes (Part 470015-07) has an incorrect expiration date listed on the brown outer shipping box. The incorrect expiration date on the brown shipping box is 30/09/2044, while the correct expiration date on the inner carton pouch labels is 30/09/2024.
This does not impact functionality or sterilisation of affected product. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Users must:
1. Follow the expiration date listed on inner cartons and pouches. Correct Expiration date for this lot is 30/09/2024.
2. Dispose of the brown shipping box. If this is not possible, take appropriate measures to ensure the correct expiry date listed on inner cartons and pouches are referenced.
3. Return of product is not necessary. However, Device Technologies Australia will provide credit for number of boxes returned.
4. Inform Device Technologies Australia of any Adverse Events or quality problems concerning the use of the drapes via the standard complaint process.
This action has been closed out on 15/02/2024 |
| Contact Information |
1300 338423 - Device Technologies |