🔍 RecallPedia

PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.

Class I - Dangerous
🏥 Medical Devices Recalled: November 10, 2020 TissueTech Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Codes: BTR192864, BTR194678, BTR192872, BTR193024 Serial ID: 20-PKP-00994,20-PKP-00988,20-PKP-00989,20-PKP-00990,20-PKP-00991,20-PKP-00992,20-PKP-00993,20-PKP-00995,20-PKP-00996, and 20-PKP-00997
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
TissueTech, Inc.
Reason for Recall:
Potential exposure of product to microbial contamination.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.

Product Codes/Lot Numbers:

Lot Codes: BTR192864, BTR194678, BTR192872, BTR193024 Serial ID: 20-PKP-00994,20-PKP-00988,20-PKP-00989,20-PKP-00990,20-PKP-00991,20-PKP-00992,20-PKP-00993,20-PKP-00995,20-PKP-00996, and 20-PKP-00997

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0551-2021

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