EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in pa
FDA device recall Z-1136-2013 · posted 2013-04-17 · Terminated
Recall details
- Recalling firm
- Endogastric Solutions Inc
- Reason for recall
- EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
- Action taken
- 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.
- Root cause
- Release of Material/Component prior to receiving test results
- Status
- Terminated
- Product code
- ODE
- Quantity affected
- 190
- Distribution
- Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA,
- Date initiated
- 2013-02-04
- Date posted
- 2013-04-17
- Date terminated
- 2013-07-02
- Location
- Redmond, WA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 (K092400) | Endogastric Solutions, Inc. | 2009-11-06 |