Merit Medical Systems, Inc.: Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, 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: 7453 units Lot/code info: All Lots/ UDI: 00810275014011

UPC codes

00810275014011

Source

Official record: FDA (Device enforcement) ↗

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