Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
This recall is currently active, issued November 6, 2023. It was issued by Pulmonx, Corp..
- Company
- Pulmonx, Corp.
- Recall Initiated
- August 31, 2023
- Posted
- November 6, 2023
- Recall Number
- Z-0235-2024
- Quantity
- 144
- Firm Location
- Redwood City, CA
- Official Source
- View on FDA website ↗
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
Lot / Code Info
UDI: (01)00811907030423(10)506590V70(17)241208, Lot: 506590-V7.0
Root Cause
Error in labeling
Action Taken
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.