Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- March 14, 2025
- Posted
- April 21, 2025
- Recall Number
- Z-1640-2025
- Quantity
- 1655 units
- Firm Location
- Jordan, UT
Reason for Recall
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Distribution
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Egypt, Israel, Saudi Arabia, Spain, Thailand, Turkey, United Arab Emirates.
Lot / Code Info
All Lots/ UDI: 00810275011089
Root Cause
Under Investigation by firm
Action Taken
On March 14, 2025, Merit Medical issued a "Urgent Medical Device Recall Notice via E-Mail, followed by mail to affected consignees. Merit asked consignees to take the following actions: 1. Read and understand this communication and the updated IFU referenced in the attached poster. 2. There is no need to return product to Merit. 3. Post the attached poster on or near the affected products so users are aware of the updated IFU. 4. Discard the current IFU with the product at point of use. 5. Ensure that applicable personnel within your organization are made aware of this communication. 6. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them. 7. If you require paper IFUs, please contact RESPONSE@merit.com. 8. Please acknowledging you are aware of the information communicated and have completed the actions required of you. 9. If you require additional product training regarding the IFU updates, please contact your Merit Sales Representative to schedule.