InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.
Recall
- Recall Number
- Z-1888-2024
- Event Number
- 94545
- Firm
- Olympus Corporation of the Americas
- FEI Number
- 2429304
- Product Code
- EOB
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- April 3, 2024
- Posted
- May 23, 2024
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229
Description
InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.
Potential for distal end of the sheath to break off during a procedure.
Consignees were mailed an URGENT MEDICAL DEVICE CORRECTION notification, dated 5/1/24. Consignees are instructed to read the provided labeling addendum, inspect their inventory to identify affected devices and place a copy of the addendum with the remaining inventory, ensure all required personnel are aware of this recall, notify those who received product further distributed, and acknowledge receipt of the recall notification using Olympus's recall portal. Consignees can report the incidence of a device breakage associated with this event to the Technical Assistance Center at 1-800-8489024, Option 1. Consignees with any questions can contact Olympus at 647-999-3203 or by email at [email protected].
Domestic: Nationwide Distribution; Foreign: Australia, Canada, Germany, Japan.
pending