🔍 RecallPedia

Spectrum Medical Quantum Standard heat exchanger

Class I - Dangerous
🏥 Medical Devices Recalled: March 22, 2021 QURA S.R.L. Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Batch Numbers: B000129, C000415, C000416, C000417
  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:
QURA S.R.L.
Reason for Recall:
Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Spectrum Medical Quantum Standard heat exchanger

Product Codes/Lot Numbers:

Batch Numbers: B000129, C000415, C000416, C000417

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2277-2021