Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All Serial Numbers
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
Product Codes/Lot Numbers:
All Serial Numbers
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1369-2016
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