FDA recall Z-0235-2024

Product

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

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

Key facts

Status

Ongoing

Initiation date

2023-08-31

Report date

2023-11-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Redwood City, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0235-2024