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Class 2 Device Recall ElastoGel Wound Dressing & ElastoGel Plus Wound Dressing (with Tape) |
![see related information](../images/related-info.gif) |
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
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Product Classification |
Dressing, Wound, Drug - Product Code FRO
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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/ Manufacturer |
Southwest Technologies Inc 1746 E Levee St N Kansas City MO 64116-4404
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For Additional Information Contact |
Edward I. Stout, Ph.D. 800-247-9951
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Manufacturer Reason for Recall |
The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit.
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FDA Determined Cause 2 |
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 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
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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.
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510(K) Database |
510(K)s with Product Code = FRO and Original Applicant = SOUTHWEST TECHNOLOGIES, INC.
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