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
Recall
- Recall Number
- Z-1136-2013
- Event Number
- 64395
- Firm
- Endogastric Solutions Inc
- FEI Number
- 3005473391
- Product Code
- ODE
- Status
- Terminated
- Root Cause
- Release of Material/Component prior to receiving test results
- Initiated
- February 4, 2013
- Posted
- April 17, 2013
- Terminated
- July 2, 2013
- Address
- 8210 154th Ave NE, Redmond, WA, 98052-3877
Description
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
EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
EndoGastric Solutions, Inc. sent an Urgent Medical Device Recall letter dated January 31, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to segregate and record lot numbers for any affected product. If no product remain in inventory customers were instructed to report such to customer service. Upon receipt of the product a credit will be issued for each device returned. For any questions customers were instructed to call 425-307-9226. For questions regarding this recall call 425-307-9200.
Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA,
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