ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot:14399518, 14399521, 14406408, 14399520, 14406410, 14406411 ; Distributed in Japan
  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:
ICU Medical, Inc.
Reason for Recall:
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3

Product Codes/Lot Numbers:

Lot:14399518, 14399521, 14406408, 14399520, 14406410, 14406411 ; Distributed in Japan

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0363-2026

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