🔍 RecallPedia

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.

Class I - Dangerous
🏥 Medical Devices Recalled: August 1, 2024 Fresenius Kabi USA Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Product Code: SET-0013-25; UDI-DI: 00811505030054; Lot number: 3010538.
  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:
Fresenius Kabi USA, LLC
Reason for Recall:
A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.

Product Codes/Lot Numbers:

Product Code: SET-0013-25; UDI-DI: 00811505030054; Lot number: 3010538.

Distribution:

Distributed in: US, CO, ID, NJ, UT

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2721-2024

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