Class 2 Device Recall ElastoGel Absorbent Wound Dressing

• Date Initiated by Firm: November 18, 2019
• Date Posted: December 13, 2019
• Recall Status: Completed
• Recall Number: Z-0687-2020
• Recall Event ID: 84293
• 510(K)Number: K872165
• Product Classification: Dressing, wound, drug - Product Code FRO
• Product: Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic
• Code Information: Lot 1917802
• Recalling Firm/ Manufacturer: Southwest Technologies Inc; 1746 E Levee St; Kansas City MO 64116-4404
• For Additional Information Contact: 800-247-9951
• Manufacturer Reason for Recall: Elasto-Gel Wound Dressing may be contaminated with mold.
• FDA Determined 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 in Commerce: 3260 eaches (5 eaches per retail box)
• Distribution: CA, GA, IL, KS, NY, OH, TN, TX, VA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.

• 510(K) Database: 510(K)s with Product Code = FRO and Original Applicant = SOUTHWEST TECHNOLOGIES, INC.