Z-0687-2020Class II

Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic

Name: Z-0687-2020 Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic
Creator: Southwest Technologies Inc
Published: 2019-11-18
License: https://open.fda.gov/license/

Southwest Technologies Inc / initiated 2019-11-18 / Terminated / root cause: manufacturing process

FDA source

Southwest Technologies Inc began a recall of Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic on 2019-11-18. FDA classified it as Class II and gives the reason as "Elasto-Gel Wound Dressing may be contaminated with mold". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0687-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-18
Posted: 2019-12-13
Terminated: 2024-08-23
Recalling firm: Southwest Technologies Inc
Product: Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic
Product code: FRO Dressing, Wound, Drug
Reason for recall: Elasto-Gel Wound Dressing may be contaminated with mold.
Root cause tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 3260 eaches (5 eaches per retail box)
Distribution: CA, GA, IL, KS, NY, OH, TN, TX, VA
Product codes and lots: Lot 1917802

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0687-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0687-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-13

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)