FDA Medical Device Recalls (openFDA)
Southwest Technologies Inc: 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.
- Recall number
- Z-0841-06
- 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.
- Status
- Terminated
- Initiated
- 2006-03-27
- Posted
- 2006-05-04
- Terminated
- 2007-12-12
- Reason
- The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit.
- 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
- 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.
- Lot, serial or model codes
- Elasto-Gel Plus, Product DR8050, Lot 111004A. Elasto-Gel, Product DR8000LV, Lot 110904A. Elasto-Gel, Product No. DR8000, Lot 102504A.
- 510(k) numbers
- ["K872165"]
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 1929833
- Firm city
- N Kansas City
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28