Reported Dec 16, 2020 · Terminated
PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
TissueTech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TissueTech, Inc. · 8305 NW 27th St Ste 101 · Doral, FL · 33122-1934
Is this the product you have?
- PROKERA Plus
- non-sterile - Product UsageBiologic corneal bandage
- Lot codes and dates
- Lot Codes
BTR192864BTR194678BTR192872
- BTR193024 Serial ID
20-PKP-0099420-PKP-0098820-PKP-0098920-PKP-0099020-PKP-0099120-PKP-0099220-PKP-0099320-PKP-0099520-PKP-00996and 20-PKP-00997
- Lot Codes
- Amount recalled
- 10 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Potential exposure of product to microbial contamination.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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