Non-sterile drape

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Kit Lot Numbers: 14082, 14091, 14104, 14106 Drape Lot Numbers: D132712, D133102, D141022, D130282
  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:
Novadaq Technologies, Inc.
Reason for Recall:
Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Non-sterile drape

Product Codes/Lot Numbers:

Kit Lot Numbers: 14082, 14091, 14104, 14106 Drape Lot Numbers: D132712, D133102, D141022, D130282

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0470-2015

Related Recalls

The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.

Jun 27, 2017 Other Medical Devices Nationwide View Details →

The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.

Jun 27, 2017 Other Medical Devices Nationwide View Details →

The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.

Jun 27, 2017 Other Medical Devices Nationwide View Details →