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.
- Company
- Southwest Technologies Inc
- Recall Initiated
- March 27, 2006
- Posted
- May 4, 2006
- Terminated
- December 12, 2007
- Recall Number
- Z-0841-06
- Quantity
- 90 cases of Product DR8000; 56 cases or Product DR8000LV; and 28 cases of Product DR8050. Each case contained 100 units.
- Firm Location
- Kansas City, MO
Reason for Recall
The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit.
Distribution
Product was distributed to direct accounts in the United States and Belgium.
Lot / Code Info
Elasto-Gel Plus, Product DR8050, Lot 111004A. Elasto-Gel, Product DR8000LV, Lot 110904A. Elasto-Gel, Product No. DR8000, Lot 102504A.
Root Cause
Other
Action Taken
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.
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