Recall Z-0687-2020 ยท FRO Dressing, Wound, Drug
Southwest Technologies Inc
Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic
| Date | Dec 13, 2019 (initiated Nov 18, 2019) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K872165 | ELASTO-GEL OCCLUSIVE DRESSING Southwest Technologies, Inc., Jun 26, 1987 |