Recall Z-1132-04 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Encision, Inc.
Encision ES4107 Disposable AEM Cord, Sterile.
| Date | Jul 22, 2004 (initiated Jul 9, 2004) |
| Status | Terminated |
| Reason | Firm found pinholes in packaging which would compromise sterility. |
| Root cause | Other |
| Action | Affected customers were notified by fax or mail on 7/15/2004. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913625 | ELECTROSCOPE MONITOR, EM-1 Electroscope, Inc., Dec 30, 1991 |