REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
Class I - DangerousWhat Should You Do?
- Check if you have this product: REF: CH3582 UDI: (01) 1 0887709 07925 7 (17) 260101 (30) 50 (10) 5125197 Lot Number: 5125197
- 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:
- Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
Product Codes/Lot Numbers:
REF: CH3582 UDI: (01) 1 0887709 07925 7 (17) 260101 (30) 50 (10) 5125197 Lot Number: 5125197
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1566-2021
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Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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