🔍 RecallPedia

The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.

Class I - Dangerous
🏥 Medical Devices Recalled: May 21, 2019 Dutch Ophthalmic USA Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294
  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:
Dutch Ophthalmic USA, Inc.
Reason for Recall:
Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.

Product Codes/Lot Numbers:

Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2252-2021

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