Encision ES4107 Disposable AEM Cord, Sterile.
FDA device recall Z-1132-04 · posted 2004-07-22 · Terminated
Recall details
- Recalling firm
- Encision, Inc.
- Reason for recall
- Firm found pinholes in packaging which would compromise sterility.
- Action taken
- Affected customers were notified by fax or mail on 7/15/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 73 units
- Distribution
- AL, CA, GA, KS, KY, MI, MN, MS, NC, NH, NY, OH, OK, SD, TN, WA, WY. Foreign Distribution to Australia and Japan. Includes military facilities in GA, MS, and Japan.
- Date initiated
- 2004-07-09
- Date posted
- 2004-07-22
- Date terminated
- 2004-12-14
- 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 |
|---|---|---|
| ELECTROSCOPE MONITOR, EM-1 (K913625) | Electroscope, Inc. | 1991-12-30 |