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U.S. Department of Health and Human Services

Class 2 Device Recall Zephyr Endobronchial Valve

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  Class 2 Device Recall Zephyr Endobronchial Valve see related information
Date Initiated by Firm August 31, 2023
Date Posted November 06, 2023
Recall Status1 Open3, Classified
Recall Number Z-0235-2024
Recall Event ID 93179
PMA Number P180002 
Product Classification Valve, pulmonary - Product Code NJK
Product Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Code Information UDI: (01)00811907030423(10)506590V70(17)241208, Lot: 506590-V7.0
Recalling Firm/
Manufacturer		 Pulmonx, Corp.
700 Chesapeake Dr
Redwood City CA 94063-4731
Manufacturer 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.
FDA Determined
Cause 2		 Error in labeling
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.
Quantity in Commerce 144
Distribution US: TN, WV, AR, PA, VA, NC, IL, IA, MA, NY, NJ, WA, CO, OR, MI, FL, OH, TX, OK, AZ, NV, WI
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = NJK and Original Applicant = Pulmonx Corporation
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