Recall Z-0687-2020— Southwest Technologies Inc

Name: FDA recall Z-0687-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-18

Class II · Terminated

Class II FDA medical device recall by Southwest Technologies Inc, initiated 2019-11-18, terminated 2024-08-23. It names one FDA 510(k) clearance: K872165. Product: Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic. Reason: Elasto-Gel Wound Dressing may be contaminated with mold..

Recalling firm: Southwest Technologies Inc
Classification: Class II
Status: Terminated
Initiated: 2019-11-18
Terminated: 2024-08-23
Firm location: Kansas City, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K872165 — ELASTO-GEL OCCLUSIVE DRESSINGSouthwest Technologies, Inc.·cleared 1987-06-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Elasto-Gel Wound Dressing may be contaminated with mold.

Data sourced from openFDA. This site is unofficial and independent of the FDA.