Z-0235-2024 Class II Ongoing
FDA device recall Z-0235-2024 was initiated by Pulmonx, Corp. on August 31, 2023 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 144.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2023
- Initiation Date
- August 31, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 144
Product Description
Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Reason for Recall
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.
Distribution Pattern
US: TN, WV, AR, PA, VA, NC, IL, IA, MA, NY, NJ, WA, CO, OR, MI, FL, OH, TX, OK, AZ, NV, WI
Code Information
UDI: (01)00811907030423(10)506590V70(17)241208, Lot: 506590-V7.0