Automated peritoneal dialysis (APD) cycler

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    N/A
  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:
Baxter Healthcare Corp.
Reason for Recall:
Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations. The tot
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Automated peritoneal dialysis (APD) cycler

Product Codes/Lot Numbers:

N/A

Distribution:

Distributed in: US, NY

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1565-2016

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