CLASS II Device recall · Reported 25 Dec 2019 · FDA Enforcement Report
Elasto-Gel Absorbent Wound Dressing recalled by Southwest Technologies
Southwest Technologies is recalling Elasto-Gel Absorbent Wound Dressing, distributed in 9 states. The recall was initiated on 18 Nov 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0687-2020
- FDA event ID
- 84293
- Recalling firm
- Southwest Technologies, Kansas City, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Nov 2019
- FDA classified
- 13 Dec 2019
- Reported
- 25 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Mold
- Device type
- Other Medical Devices
Timeline
| 18 Nov 2019 | Recall initiated by company | |
| 13 Dec 2019 | Classified by FDA | +25 days |
| 25 Dec 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Elasto-Gel Wound Dressing may be contaminated with mold.
Product as listed by the FDA
Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic
Where it was distributed
CA, GA, IL, KS, NY, OH, TN, TX, VA
CaliforniaGeorgiaIllinoisKansasNew YorkOhioTennesseeTexasVirginia
Questions about this recall
Why was it recalled?
Elasto-Gel Wound Dressing may be contaminated with mold.
Which lots are affected?
Lot 1917802
Where was it sold?
CA, GA, IL, KS, NY, OH, TN, TX, VA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Southwest Technologies
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|---|---|---|---|---|---|
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