Recall Z-0235-2024— Pulmonx, Corp.

Class II · Ongoing

Class II FDA medical device recall by Pulmonx, Corp., initiated 2023-08-31. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..

Recalling firm
Pulmonx, Corp.
Classification
Class II
Status
Ongoing
Initiated
2023-08-31
Firm location
Redwood City, CA, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.