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U.S. Department of Health and Human Services

Class 2 Device Recall ElastoGel Wound Dressing & ElastoGel Plus Wound Dressing (with Tape)

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  Class 2 Device Recall ElastoGel Wound Dressing & ElastoGel Plus Wound Dressing (with Tape) see related information
Date Initiated by Firm March 27, 2006
Date Posted May 04, 2006
Recall Status1 Terminated 3 on December 12, 2007
Recall Number Z-0841-06
Recall Event ID 35051
510(K)Number K872165  
Product Classification Dressing, Wound, Drug - Product Code FRO
Product 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.
Code Information Elasto-Gel Plus, Product DR8050, Lot 111004A. Elasto-Gel, Product DR8000LV, Lot 110904A. Elasto-Gel, Product No. DR8000, Lot 102504A.
Recalling Firm/
Southwest Technologies Inc
1746 E Levee St
N Kansas City MO 64116-4404
For Additional Information Contact Edward I. Stout, Ph.D.
Manufacturer Reason
for Recall
The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit.
FDA Determined
Cause 2
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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRO and Original Applicant = SOUTHWEST TECHNOLOGIES, INC.