ES0110, AEM Disposable Hook Scissors, 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosur
FDA device recall Z-2397-2011 · posted 2011-05-31 · Terminated
Recall details
- Recalling firm
- Encision, Inc.
- Reason for recall
- Sterility may be compromised due to holes in packaging.
- Action taken
- Encision, Inc. sent an Important Safety Notice letter dated April 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to either carefully inspect any remaining pouches for readily visible holes in the Tyvek pouch, or return the affected lots to Encision for inspection. Customers were also asked to fill in and fax back the attached Confirmation to 303-444-2693.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 129 Ten-Count Boxes
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Australia and New Zealand
- Date initiated
- 2011-04-07
- Date posted
- 2011-05-31
- Date terminated
- 2011-08-09
- Location
- Boulder, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD (K912780) | Electroscope, Inc. | 1991-12-30 |