PROKERA, non-sterile - Product Usage: Biologic corneal bandage.
Reported: December 16, 2020 Initiated: November 10, 2020 #Z-0550-2021
Product Description
PROKERA, non-sterile - Product Usage: Biologic corneal bandage.
Reason for Recall
Potential exposure of product to microbial contamination.
Details
- Recalling Firm
- TissueTech, Inc.
- Units Affected
- 63 units
- Distribution
- 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.
- Location
- Doral, FL
Frequently Asked Questions
What product was recalled? ▼
PROKERA, non-sterile - Product Usage: Biologic corneal bandage.. Recalled by TissueTech, Inc.. Units affected: 63 units.
Why was this product recalled? ▼
Potential exposure of product to microbial contamination.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 16, 2020. Severity: Moderate. Recall number: Z-0550-2021.
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