REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock; Syringe Transfer Set w/MicroClave, w/ChemoLock Port - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Class I - DangerousWhat Should You Do?
- Check if you have this product: REF: CL3960 UDI: (01) 1 0557709 08327 (17) 260101 (30) 50 (10) 5125262 Lot Number: 5125262
- 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 CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock; Syringe Transfer Set w/MicroClave, w/ChemoLock Port - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Product Codes/Lot Numbers:
REF: CL3960 UDI: (01) 1 0557709 08327 (17) 260101 (30) 50 (10) 5125262 Lot Number: 5125262
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1574-2021
Related Recalls
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.