Recall Z-0629-2024 ยท QEY Mechanical Thrombolysis Catheter
Merit Medical Systems, Inc.
Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
| Date | Jan 2, 2024 (initiated Nov 6, 2023) |
| Status | Open, Classified |
| Reason | The sterility of microcatheter and infusion system devices cannot be guaranteed. |
| Root cause | Package design/selection |
| Action | On November 6, 2023, Merit Medical issued a Urgent Medical Device Recall Notice to affected consignees via Email or UPS. Merit Medical asked consignees to take the following actions: 1. 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 been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immed |
| Quantity | 3 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, MA, MD, MN, MO, NH, NJ, NSW, NV, NY, UT, WI and the countries of Argentina, Australia, Belgium, China, France, Germany, Guam, Hong Kong, Italy, Mexico, Netherlands, Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992231 | FOUNTAIN Infusion Catheter and Occluding Guide Wire Merit Medical Systems, Inc., Jul 23, 1999 |