Recall Z-0270-2023 ยท FGX Snare, Non-Electrical
Endo-Therapeutics, Inc.
eSuction Small Cavity, Model ET2005
| Date | Nov 18, 2022 (initiated Oct 24, 2022) |
| Status | Terminated |
| Reason | Improper device regulatory classification |
| Root cause | Other |
| Action | Endo-Therapeutics, Inc. notified consignees via FedEx Overnight letter sent on 10/24/2022. The letter instructed consignees to cease further distribution of the affected devices immediately, notification to accounts if further distribution, return affected devices and complete and return the response form. |
| Quantity | 28 devices |
| Distribution | US distribution to Florida and Pennsylvania |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.