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Endogastric Solutions Inc recalls EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in p
Recalled April 24, 2013 · FDA recall Z-1136-2013 · Endogastric Solutions
Hazard
EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians. · FDA Class II
Units
190
Sold at
Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA,
Description
EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
Product
EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***" Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis
Manufacturer(s)
Endogastric Solutions Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →