FDA Medical Device Recalls (openFDA)
Southwest Technologies Inc: Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic
- Recall number
- Z-0687-2020
- Recalling firm
- Southwest Technologies Inc
- Product
- Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic
- Status
- Terminated
- Initiated
- 2019-11-18
- Posted
- 2019-12-13
- Terminated
- 2024-08-23
- Reason
- Elasto-Gel Wound Dressing may be contaminated with mold.
- Root cause
- Equipment maintenance
- Action
- Customers were first notified November 18, 2019 via email. The email identified the affected product, provided shipping dates, stated the reason for the recall, instructed that product stop being used, and asked for unused product to be returned. A response form was asked to be completed and returned. Questions can be directed to 1-800-247-9951 or email a recall@elastogel.com.
- Quantity
- 3260 eaches (5 eaches per retail box)
- Distribution
- CA, GA, IL, KS, NY, OH, TN, TX, VA
- Lot, serial or model codes
- Lot 1917802
- 510(k) numbers
- ["K872165"]
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 1929833
- Firm city
- 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