7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which 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: Lot number 3482848, UDI (01) 0 0887709 01806 8 (17) 220701 (30) 01 (10) 3482848; lot number 3511823, UDI (01) 0 0887709 01806 8 (17) 220801 (30) 01 (10) 3511823; lot number 3516092, UDI (01) 0 0887709 01806 8 (17) 220801 (30) 01 (10) 3516092; and lot number 3545075, UDI (01) 0 0887709 01806 8 (17) 221001 (30) 01 (10) 3545075.
- 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:
- The infusion sets were manufactured with an incorrect spin collar.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which 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:
Lot number 3482848, UDI (01) 0 0887709 01806 8 (17) 220701 (30) 01 (10) 3482848; lot number 3511823, UDI (01) 0 0887709 01806 8 (17) 220801 (30) 01 (10) 3511823; lot number 3516092, UDI (01) 0 0887709 01806 8 (17) 220801 (30) 01 (10) 3516092; and lot number 3545075, UDI (01) 0 0887709 01806 8 (17) 221001 (30) 01 (10) 3545075.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1345-2018
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