Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic
FDA device recall Z-0687-2020 · posted 2019-12-13 · Terminated
Recall details
- Recalling firm
- Southwest Technologies Inc
- Reason for recall
- Elasto-Gel Wound Dressing may be contaminated with mold.
- Action taken
- 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.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- FRO
- Quantity affected
- 3260 eaches (5 eaches per retail box)
- Distribution
- CA, GA, IL, KS, NY, OH, TN, TX, VA
- Date initiated
- 2019-11-18
- Date posted
- 2019-12-13
- Date terminated
- 2024-08-23
- Location
- Kansas City, MO
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELASTO-GEL OCCLUSIVE DRESSING (K872165) | Southwest Technologies, Inc. | 1987-06-26 |