Recall Z-2742-2018 ยท FMF Syringe, Piston
Merit Medical Systems, Inc.
1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
| Date | Feb 2, 2018 |
| Status | Terminated |
| Reason | Supplier manufacturing defect with the syringe plunger tip. |
| Root cause | Nonconforming Material/Component |
| Action | On February 2, 2018 Merit Medical sent a "URGENT PRODUCT RECALL NOTICE" letter to all their consignees requesting the following actions; Actions required of you: 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 been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared w |
| Quantity | 22,234 |
| Distribution | Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MD, ME, MI, MN, MO, NC, ND, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TB, TN, TX, UT, VA, WI, and WV; and countries of; Canada, Colombia, France, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173601 | Merit Syringe Merit Medical Systems, Inc., Jan 31, 2018 |