Summary
The FDA issued a Class II for Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP by Pulmonx, Corp.. Reason: Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 Decemb.
Details
Source
Device Recall
External ID
Z-0235-2024
Action Date
2023-11-15
Status
Ongoing
Category
device
Product Description
Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Lot/Code Info: UDI: (01)00811907030423(10)506590V70(17)241208, Lot: 506590-V7.0
Quantity Affected: 144
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-31
Company
Redwood City, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pulmonx, Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pulmonx, Corp. have FDA actions?
This is the only FDA action we have on record for Pulmonx, Corp. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0235-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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