Recall Z-0841-06 ยท FRO Dressing, Wound, Drug
Southwest Technologies Inc
Elasto-Gel Wound Dressings, 3 product codes: DR8050, DR 8000, and DR 8000LV (for foreign distribution only), 4'' x 4'', Sterile, each package contains 1 wound dressing, 5 packages per intermediate box, 20 intermediate boxes (100 pkgs) per case. The label shows the product is Manufactured by Southwest Technologies, Inc., North Kansas City, MO.
| Date | May 4, 2006 (initiated Mar 27, 2006) |
| Status | Terminated |
| Reason | The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit. |
| Root cause | Other |
| Action | Recall letters were sent to all direct accounts via certified mail on 3/27/2006. The consignees were requested to return any affected product on hand and if the product was further distributed, notify their customers. |
| Quantity | 90 cases of Product DR8000; 56 cases or Product DR8000LV; and 28 cases of Product DR8050. Each case contained 100 units |
| Distribution | Product was distributed to direct accounts in the United States and Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K872165 | ELASTO-GEL OCCLUSIVE DRESSING Southwest Technologies, Inc., Jun 26, 1987 |