Recall Z-1156-06 ยท GZC Stimulator, Neuromuscular, Implanted
Adept-Med International Inc
Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203, 3202, 3201, 3200, 3206; Product is manufactured and distributed by Adept-Med International, Inc., 665 Pleasant Valley Rd., Diamond Springs, CA 95619
| Date | Jun 22, 2006 (initiated Aug 17, 2004) |
| Status | Terminated |
| Reason | Devices for which sterility may be compromised as evidenced by a loss of package integrity. |
| Root cause | Other |
| Action | On 8/13/04, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned. |
| Quantity | 7,600 units |
| Distribution | Nationwide-The product was released for distribution to 249 consignees in US. The firm identified 242 hospitals and 7 distributors. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, pharmacists, hospitals who received the recalled product. |
| FDA record | Open on fda.gov |