Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit per pouch; 50 pouches per case
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Code: 163350455, Lot number (UDI Number): 855935H (20887787007316, 10887787007319), 855965H (20887787007316, 10887787007319), 876145H (20887787007316, 10887787007319), 885395H (20887787007316, 10887787007319), 896135H (20887787007316, 10887787007319), 936605H (20887787007316, 10887787007319), 3843263 (20887787007316, 10887787007319), 3864786 (20887787007316, 10887787007319)
- 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 Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit per pouch; 50 pouches per case
Product Codes/Lot Numbers:
Product Code: 163350455, Lot number (UDI Number): 855935H (20887787007316, 10887787007319), 855965H (20887787007316, 10887787007319), 876145H (20887787007316, 10887787007319), 885395H (20887787007316, 10887787007319), 896135H (20887787007316, 10887787007319), 936605H (20887787007316, 10887787007319), 3843263 (20887787007316, 10887787007319), 3864786 (20887787007316, 10887787007319)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0129-2020
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