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Recall Observatory FDA recall evidence

Device product

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

Z-0235-2024

August 31, 2023

Class II

Product summary

Firm
Pulmonx, Corp.
Event
Event 93179
Status
Ongoing
Classification
Class II
Quantity
144
Official record key
device-enforcement:Z-0235-2024

Official wording

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.

Code information: UDI: (01)00811907030423(10)506590V70(17)241208, Lot: 506590-V7.0

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.