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TissueTech, Inc. recalls PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
Recalled December 16, 2020 · FDA recall Z-0551-2021 · TissueTech
Hazard
Potential exposure of product to microbial contamination. · FDA Class II
Units
10 units
Sold at
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.
Description
Potential exposure of product to microbial contamination.
Product
PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
Manufacturer(s)
TissueTech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →