FDA Enforcement
Class II
Ongoing
Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Recall: Z-0235-2024
·
Reported November 15, 2023
Enforcement
- Recall Number
- Z-0235-2024
- Event ID
- 93179
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Pulmonx, Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 15, 2023
- Initiation Date
- August 31, 2023
- Classification Date
- November 6, 2023
- Address
- 700 Chesapeake Dr, Redwood City, CA, 94063-4731, United States
Description
Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Reason
Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024.
Code Info
UDI: (01)00811907030423(10)506590V70(17)241208, Lot: 506590-V7.0
Distribution
US: TN, WV, AR, PA, VA, NC, IL, IA, MA, NY, NJ, WA, CO, OR, MI, FL, OH, TX, OK, AZ, NV, WI
Quantity
144