🔍 RecallPedia

Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activity

Class I - Dangerous
🏥 Medical Devices Recalled: March 1, 2011 Terumo Cardiovascular Systems Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: ML13, MM04. Manufacturing datese September 13, 2010 through October 4, 20 I 0.
  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:
Terumo Cardiovascular Systems Corp
Reason for Recall:
Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activity

Product Codes/Lot Numbers:

Lot Numbers: ML13, MM04. Manufacturing datese September 13, 2010 through October 4, 20 I 0.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0157-2015

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