TissueTech recalls specific batches of non-sterile PROKERA biologic corneal bandages due to potential microbial contamination. Affected lots and serial numbers listed. Consumers should check their product details and contact TissueTech for guidance.
Potential exposure of product to microbial contamination.
TissueTech is recalling certain batches of non-sterile PROKERA biologic corneal bandages because they may have been contaminated with microbes. This could lead to infections or other complications if used improperly. If you have the recalled product, you should stop using it and contact TissueTech for instructions.
The product is non-sterile and may have been exposed to microbes during manufacturing or storage. If the bandage is used without proper sterilization, it could introduce infections into the eye, leading to complications like inflammation or vision problems.
People who have received the recalled PROKERA biologic corneal bandages for eye treatment. Those with compromised immune systems or existing eye conditions may be at higher risk of infection.
Check the lot code on the packaging, which is listed as BTR192864, BTR194678, BTR192872, or BTR193024. Also, look for the serial ID numbers starting with 20-PK16- (e.g., 20-PK16-00761).
Review the lot code and serial ID on your PROKERA biologic corneal bandage to see if it matches the listed numbers.
Reach out to TissueTech directly for specific instructions on how to handle the recalled product.
The product may have been contaminated with microbes during manufacturing or storage, which could lead to eye infections if used improperly.
Check the lot code and serial ID on your product. If it matches the listed numbers, stop using it and contact TissueTech for instructions.
People with weakened immune systems or existing eye conditions may be at higher risk of infection from microbial contamination.
We’ve drafted a message you can send TissueTech to request your refund or repair — edit it as you like.
Subject: Recall Z-0550-2021 — TissueTech TissueTech Hello, I own a TissueTech that is covered by recall Z-0550-2021 from TissueTech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
