TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
This recall is currently active, issued December 14, 2023. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- September 28, 2023
- Posted
- December 14, 2023
- Recall Number
- Z-0557-2024
- Quantity
- 75
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.
Distribution
Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA, GA, IL, IN, MA, MD, MI, NC, NJ, OH, TX, UT, VA, WA, WV & AP (Armed Forces Pacific) and the countries of OUS: EMEA, Japan and Australia.
Lot / Code Info
UDI-DI: 04953170340215 & UDI-DI: 04953170061998. Serial numbers: 2515143, 2515181, 2515449, 2515549, 2615760, 2615761, 2615763, 2615825, 2615830, 2615831, 2616057, 2616130, 2616199, 2716417, 2817430, 2917855, 2917867, 2917997, 2918003, 2918010, 2918012, 2918030, 2018337, 2018435, 2018486, 2018543, 2018571, 2018675, 2319768, 2319820, 2510582, 2621001.
Root Cause
Under Investigation by firm
Action Taken
An Urgent Medical Device notification dated November 1, 2023 issued via UPS Ground. The notice advises customers to examine inventory for affected serial numbers and quarantine affected product. Contact Olympus Customer Solutions Team (1-800-848-9024, option 3) to arrange for for return. Olympus will inspect and repair if necessary. Customers are to forward notice to any facility affected product may have been transferred to. Olympus requests that you acknowledge receipt of this letter with Tara.Safi@Olympus.com.