Recall Z-1796-2020 ยท DXC Clamp, Vascular
Merit Medical Systems, Inc.
PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
| Date | Mar 11, 2020 |
| Status | Terminated |
| Reason | During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to maintain pressure/compression. This may result in a lack of hemostasis resulting in bleeding or a delay in treatment; the defect is likely to be visually identified by the clinician before use or identified during inflation of the balloon. |
| Root cause | Other |
| Action | On 03/11/2020, Urgent Product Recall Notices were mailed via second day service. The recalling firm requests that customers immediately stop using, quarantine, and return the affected lots. Further, they requested that customers make personnel within their organization aware of this field action. If the product was further distributed to other facilities, institutions, or manufacturers, customers were asked to ensure this notice was immediately shared with them and note the quantity distributed on the customer response form. Customers with additional questions were encouraged to call 801-208- |
| Quantity | 1932 |
| Distribution | U.S.: NV, IL, VA, PA, CA, AR, MA, GA, OH, NJ, TX, FL, NC, SC, MI, NH, CO, AL, MN, KS, NM, AZ, ID, MD, NY, OR, DC, DE, MO, IN, WI, IA, TN. O.U.S.: Switzerland, Hong Kong, Spain, Portugal, Canada, Singapore, United Arab Emirates, Mexico, United Kingdom, France, Japan, Germany, Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180723 | PreludeSYNC DISTAL Radial Compression System Merit Medical Systems, Inc., Apr 17, 2018 |