Z-0841-06

Elasto-Gel Wound Dressings, 3 product codes: DR8050, DR 8000, and DR 8000LV (for foreign distribution only)...

Name: Z-0841-06 Elasto-Gel Wound Dressings, 3 product codes: DR8050, DR 8000, and DR 8000LV (for foreign distribution only)...
Creator: Southwest Technologies Inc
Published: 2006-03-27
License: https://open.fda.gov/license/

Southwest Technologies Inc / initiated 2006-03-27 / Terminated / root cause: labeling and UDI

FDA source

Southwest Technologies Inc began a recall of 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... on 2006-03-27. The reason FDA records is "The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0841-06
Status: Terminated
Initiated: 2006-03-27
Posted: 2006-05-04
Terminated: 2007-12-12
Recalling firm: Southwest Technologies Inc
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.
Product code: FRO Dressing, Wound, Drug
Reason for recall: The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Elasto-Gel Plus, Product DR8050, Lot 111004A. Elasto-Gel, Product DR8000LV, Lot 110904A. Elasto-Gel, Product No. DR8000, Lot 102504A.

Product code FRO

K872165UnclassifiedElasto-Gel Occlusive DressingSouthwest Technologies, Inc. / cleared 1987-06-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)