TissueTech recalls specific lots of non-sterile PROKERA Slim corneal bandages due to potential microbial contamination. Affected users should check their lot codes or serial IDs and contact TissueTech for guidance.
Potential exposure of product to microbial contamination.
TissueTech is recalling certain lots of non-sterile PROKERA Slim corneal bandages because they may have been contaminated with microbes. This could lead to infections or other complications for eye users. The recall affects specific batch numbers and serial IDs.
The recalled bandages may have been exposed to microbes during manufacturing, which could lead to infections if used in the eye. Since these are non-sterile products, the risk of contamination is higher than sterile alternatives.
People who have the recalled PROKERA Slim corneal bandages for eye treatment are affected. Those with the specific lot codes or serial IDs listed in the recall are most at risk.
Check the lot code (BTR192864, BTR194678, etc.) or serial ID (20-PKS-14212 to 20-PKS-14303) on the product packaging. The product is a non-sterile biologic corneal bandage used for eye treatment.
Look for the lot code (BTR192864, BTR194678, etc.) or serial ID (20-PKS-14212 to 20-PKS-14303) on the bandage packaging.
Reach out to TissueTech for instructions on whether the product is affected and what to do next.
The recall is due to potential microbial contamination in specific lots of non-sterile PROKERA Slim corneal bandages, which could lead to infections if used in the eye.
Check the lot code (BTR192864, BTR194678, etc.) or serial ID (20-PKS-14212 to 20-PKS-14303) on the product packaging.
Contact TissueTech directly for guidance on whether to stop using the product and what steps to take next.
We’ve drafted a message you can send TissueTech to request your refund or repair — edit it as you like.
Subject: Recall Z-0552-2021 — TissueTech TissueTech Hello, I own a TissueTech that is covered by recall Z-0552-2021 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.
