Pulmonx, Corp. recalls Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP

Recall date

August 31, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0235-2024

FDA classification

Class II

Brand / firm

Pulmonx, Corp.

Sold / distributed

US: TN, WV, AR, PA, VA, NC, IL, IA, MA, NY, NJ, WA, CO, OR, MI, FL, OH, TX, OK, AZ, NV, WI

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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