Merit Medical Systems, Inc.: Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly

Hazard

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

Details from the source

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. Quantity: 1655 units Lot/code info: All Lots/ UDI: 00810275011089

UPC codes

00810275011089

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.