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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 FirmMarch 27, 2006
Date PostedMay 04, 2006
Recall Status1 Terminated 3 on December 12, 2007
Recall NumberZ-0841-06
Recall Event ID 35051
510(K)NumberK872165 
Product Classification Dressing, Wound, Drug - Product Code FRO
ProductElasto-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
For Additional Information ContactEdward I. Stout, Ph.D.
800-247-9951
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		Other
ActionRecall 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 Commerce90 cases of Product DR8000; 56 cases or Product DR8000LV; and 28 cases of Product DR8050. Each case contained 100 units.
DistributionProduct was distributed to direct accounts in the United States and Belgium.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FRO
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