Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per case
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Code: 163730455, Lot number (UDI Number): 896225H (20887787007408, 10887787007401), 916845H (20887787007408, 10887787007401), 925825H (20887787007408, 10887787007401), 948155H (20887787007408, 10887787007401)
- 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:
- Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per case
Product Codes/Lot Numbers:
Product Code: 163730455, Lot number (UDI Number): 896225H (20887787007408, 10887787007401), 916845H (20887787007408, 10887787007401), 925825H (20887787007408, 10887787007401), 948155H (20887787007408, 10887787007401)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0132-2020
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