Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
Class I - DangerousWhat Should You Do?
- Check if you have this product: Asante Catalog number: FG-4127-5, FG-4127T Unomedical Item number: 87-060-2662 Lot numbers: 0230119 0230123 5023420 5031106
- 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:
- Asante Solutions, Inc.
- Reason for Recall:
- Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
Product Codes/Lot Numbers:
Asante Catalog number: FG-4127-5, FG-4127T Unomedical Item number: 87-060-2662 Lot numbers: 0230119 0230123 5023420 5031106
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0595-2014
Related Recalls
Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.