Recall Z-0235-2024 ยท NJK Valve, Pulmonary
Pulmonx, Corp.
Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
| Date | Nov 6, 2023 (initiated Aug 31, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.