FDA Device recall Z-1912-2023
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
- FDA Device
- Class II
- ongoing
- Published 2023-06-21
On 2023-06-21 the FDA classified a Class II recall of Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only by Merit Medical Systems, citing there is a potential that valve assemblies will not open. preventing fluid from draining.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1912-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-22 |
| Published | 2023-06-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
Reason
There is a potential that valve assemblies will not open. preventing fluid from draining.
Identifiers
| code_info | Lot # I2632727, I2558682, I2623159, I2618461 ; UDI-DI: 00884450398173 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1912-2023%22
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