| Date Initiated by Firm | October 24, 2022 |
|---|
| Date Posted | November 18, 2022 |
|---|
| Recall Status1 |
Terminated 3 on January 24, 2024 |
| Recall Number | Z-0270-2023 |
|---|
| Recall Event ID |
91074 |
| Product Classification |
Snare, non-electrical - Product Code FGX
|
| Product | eSuction Small Cavity, Model ET2005 |
|---|
| Code Information |
Model Number: ET2005; UDI-DI: 00816207021393; Lot Numbers: 447037, 447204 |
Recalling Firm/
Manufacturer |
Endo-Therapeutics, Inc.
15201 Roosevelt Blvd Ste 104
Clearwater FL 33760-3559
|
| For Additional Information Contact | Debbie Reed
727-538-9570 |
|---|
Manufacturer Reason
for Recall | Improper device regulatory classification |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 28 devices |
|---|
| Distribution | US distribution to Florida and Pennsylvania |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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