eSuction Small Cavity, Model ET2005
Hazard
Improper device regulatory classification
What You Should Do
Remedy
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.
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Products
eSuction Small Cavity, Model ET2005
- Brand
- Endo-Therapeutics, Inc.
- UPC
- Model Number: ET2005; UDI-DI: 00816207021393; Lot Numbers: 447037, 447204
Units Affected
28 devices