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.
FDA Recall Z-0841-06 · Posted 2006-05-04
Recalling FirmSouthwest Technologies Inc
Recall StatusTerminated
Product CodeFRO
Date Initiated2006-03-27
Date Terminated2007-12-12
Product Quantity90 cases of Product DR8000; 56 cases or Product DR8000LV; and 28 cases of Product DR8050. Each case contained 100 units.
Reason for Recall
The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit.
Firm 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.
Root Cause
Other
Distribution Pattern
Product was distributed to direct accounts in the United States and Belgium.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.