Recall Z-1916-2023 ยท PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Merit Medical Systems, Inc.
Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
| Date | Jun 14, 2023 (initiated Apr 22, 2023) |
| Status | Open, Classified |
| Reason | There is a potential that valve assemblies will not open. preventing fluid from draining. |
| Root cause | Process control |
| Action | Beginning on April 22, 2023, Merit Medical issued an "Urgent Medical Device Recall Notice" to affected consignees via FedEx and UPS. On May 31, 2023, Merit Medical expanded the scope and notified additional consignees. Merit Medical asked consignees to take the following actions: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has bee |
| Quantity | 2559 units |
| 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 Ki |
| FDA record | Open on fda.gov |