PROKERA Plus recalled over sterility concerns
- Recall date
- November 10, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- TissueTech, Inc. recalls PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
- Recall number
- Z-0551-2021
- FDA classification
- Class II
- Brand / firm
- TissueTech, Inc.
- Sold / distributed
- US Nationwide distribution including in the states of FL, MN, NY, NC, SC, NJ, GA, PA, MD, DC, OH, WA, MI, CO, KS, TN, ME, AL, AR, TX, KY, MA, CA, CT, and OK.
Why it was recalled
Potential exposure of product to microbial contamination.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
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