PlainRecalls
FDA Devices Moderate Class II Ongoing

Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP

Reported: November 15, 2023 Initiated: August 31, 2023 #Z-0235-2024

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.

Details

Recalling Firm
Pulmonx, Corp.
Units Affected
144
Distribution
US: TN, WV, AR, PA, VA, NC, IL, IA, MA, NY, NJ, WA, CO, OR, MI, FL, OH, TX, OK, AZ, NV, WI
Location
Redwood City, CA

Frequently Asked Questions

What product was recalled?
Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP. Recalled by Pulmonx, Corp.. Units affected: 144.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 15, 2023. Severity: Moderate. Recall number: Z-0235-2024.