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Terminated

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

FDA Recall Z-0687-2020 · Posted 2019-12-13

Recalling FirmSouthwest Technologies Inc
Recall StatusTerminated
Product CodeFRO
Date Initiated2019-11-18
Date Terminated2024-08-23
Product Quantity3260 eaches (5 eaches per retail box)

Reason for Recall

Elasto-Gel Wound Dressing may be contaminated with mold.

Firm 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].

Root Cause

Equipment maintenance

Distribution Pattern

CA, GA, IL, KS, NY, OH, TN, TX, VA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K872165ELASTO-GEL OCCLUSIVE DRESSINGSouthwest Technologies, Inc. · 1987-06-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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