🔍 RecallPedia

PROKERA Slim, 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-PKS-14212,20-PKS-14213,20-PKS-14214,20-PKS-14215,20-PKS-14216,20-PKS-14217,20-PKS-14218,20-PKS-14219,20-PKS-14202,20-PKS-14203,20-PKS-14204,20-PKS-14205,20-PKS-14191,20-PKS-14192,20-PKS-14193,20-PKS-14194,20-PKS-14195,20-PKS-14196,20-PKS-14197,20-PKS-14198,20-PKS-14199,20-PKS-14200,20-PKS-14207,20-PKS-14208,20-PKS-14209,20-PKS-14210,20-PKS-14211,20-PKS-14206,20-PKS-14188,20-PKS-14189,20-PKS-14190,20-PKS-14201,20-PKS-14304,20-PKS-14272,20-PKS-14273,20-PKS-14274,20-PKS-14275,20-PKS-14276,20-PKS-14277,20-PKS-14290,20-PKS-14291,20-PKS-14292,20-PKS-14293,20-PKS-14294,20-PKS-14278,20-PKS-14279,20-PKS-14280,20-PKS-14297,20-PKS-14307,20-PKS-14308,20-PKS-14298,20-PKS-14309,20-PKS-14310,20-PKS-14311,20-PKS-14312,20-PKS-14313,20-PKS-14281,20-PKS-14282,20-PKS-14283,20-PKS-14284,20-PKS-14285,20-PKS-14286,20-PKS-14287,20-PKS-14288,20-PKS-14289,20-PKS-14305,20-PKS-14306,20-PKS-14295,20-PKS-14296,20-PKS-14314,20-PKS-14299,20-PKS-14300,20-PKS-14301,20-PKS-14302, and 20-PKS-14303
  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 Slim, non-sterile - Product Usage: Biologic corneal bandage.

Product Codes/Lot Numbers:

Lot Codes: BTR192864, BTR194678, BTR192872, BTR193024 Serial ID: 20-PKS-14212,20-PKS-14213,20-PKS-14214,20-PKS-14215,20-PKS-14216,20-PKS-14217,20-PKS-14218,20-PKS-14219,20-PKS-14202,20-PKS-14203,20-PKS-14204,20-PKS-14205,20-PKS-14191,20-PKS-14192,20-PKS-14193,20-PKS-14194,20-PKS-14195,20-PKS-14196,20-PKS-14197,20-PKS-14198,20-PKS-14199,20-PKS-14200,20-PKS-14207,20-PKS-14208,20-PKS-14209,20-PKS-14210,20-PKS-14211,20-PKS-14206,20-PKS-14188,20-PKS-14189,20-PKS-14190,20-PKS-14201,20-PKS-14304,20-PKS-14272,20-PKS-14273,20-PKS-14274,20-PKS-14275,20-PKS-14276,20-PKS-14277,20-PKS-14290,20-PKS-14291,20-PKS-14292,20-PKS-14293,20-PKS-14294,20-PKS-14278,20-PKS-14279,20-PKS-14280,20-PKS-14297,20-PKS-14307,20-PKS-14308,20-PKS-14298,20-PKS-14309,20-PKS-14310,20-PKS-14311,20-PKS-14312,20-PKS-14313,20-PKS-14281,20-PKS-14282,20-PKS-14283,20-PKS-14284,20-PKS-14285,20-PKS-14286,20-PKS-14287,20-PKS-14288,20-PKS-14289,20-PKS-14305,20-PKS-14306,20-PKS-14295,20-PKS-14296,20-PKS-14314,20-PKS-14299,20-PKS-14300,20-PKS-14301,20-PKS-14302, and 20-PKS-14303

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0552-2021

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