Merit Medical Systems, Inc. Recall 92301
Description: Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
Merit Medical Systems, Inc. Recall 92301 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1915-2023 |
| Event ID | 92301 |
| Event Description | Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico. |
| Quantity | 1054 units |
| Recall Reason | There is a potential that valve assemblies will not open. preventing fluid from draining. |
| Device Classification | 20230621 |
| Device Code Info | Lot # I2614171, I2559314, I2546596, I2614170, I2538442, I2564679, I2548181, I2623231; UDI-DI: 00884450394946 |
| Center Classification Date | 20230614 |
| Recall Initiation Date | 20230422 |
| Recalling Firm | Merit Medical Systems, Inc. |
| Initial Notification | Letter |
| Similar To |