Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-0235-2024 · Posted 2023-11-06

Recalling FirmPulmonx, Corp.
Recall StatusOpen, Classified
Product CodeNJK
Date Initiated2023-08-31
Product Quantity144

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.

Firm Action

On 8/31/23, correction notices were emailed to customers who were asked to do the following: 1) The affected lot can be used without risk to the patient until 08 December 2024. In addition, this lot was manufactured on 2021-12-08. 2) Check your inventory and keep this letter with any remaining product of the affected lot to support the corrected manufacture and expiration date. 3) Send a response email acknowledging receipt that includes the number of affected devices remaining at your site. Customers with questions can call 650-743-6848.

Root Cause

Error in labeling

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑