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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-01067-1
Product Name/Description	Paparella-Type Vent Tube - 240044 Lot Number: SM280573 ARTG 146612 (Olympus Australia Pty Ltd - Tube, tympanostomy)
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	11/12/2023
Responsible Entity	Olympus Australia Pty Ltd
Reason/Issue	Globally, Olympus has received six (6) complaints regarding a missing expiration date on the primary packaging of the Paparella-Type Vent Tube device. No adverse events have been reported for this issue. Through the sponsor’s investigation, it is noted that the issue is confined to Lot Number SM280573 and that the expiration date is missing from the primary (inner) packaging only. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot. In the event the expiration date is unable to be verified and/or is missing on the primary packaging of the Paparella-Type Vent Tube this can lead to a delay in initiating the procedure, or if noticed during the procedure it can prolong the surgery to replace the device, or potentially it can result in the cancellation of the procedure if there is no alternative device replacement available.
Recall Action	Recall
Recall Action Instructions	Customers are to: - Inspect their inventory, identify affected products, cease use, and quarantine them. - Return affected products to Olympus Australia Pty Ltd at no charge. Olympus will issue a credit upon return of the affected items.
Contact Information	1300 132 992 - Olympus Australia Pty Ltd