| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00991-1 |
| Product Name/Description |
MAJ-1606 instrument adaptor (designed for use with the Olympus MAJ-1607 instrument channel water tube)
Item Codes: K10016091 – MAJ-1606
Lot Numbers: 20115441 and 20116536
ARTG Number: 222646 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
Small puncture marks that are not easily visible by eye have been found on the packaging of the MAJ-1606. This damage was caused by variations in the packaging process.
A sample of devices with these small puncture marks was sent by the manufacturer for bio-burden testing. This testing concluded that no bacterial contamination was detected from any of the adaptors sampled.
Both the manufacturer and Olympus have not received any complaints of injury associated with compromised sterile packaging, however, as a precaution Olympus is recalling the two affected lot numbers. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to immediately cease use of any affected product they have and to quarantine affected units until they can be returned to Olympus as per the instructions in the Customer Letter. A credit or replacement will then be issued free of charge for any returned product. This action has been closed-out on 05/09/2016. |
| Contact Information |
03 9265 5435 - Olympus Australia |