FDAFDA · Food and drugs·Recall number Z-1342-2018
6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS, 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).
Published April 18, 2018 · Recall initiated: February 5, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The infusion sets were manufactured with an incorrect spin collar.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.
- Lot
- Lot numbers 3474877, UDI (01) 0 0887709 074578 (30) 500 (10)3474877; and Lot number 3481246, UDI (01) 0 0887709 074578 (30) 500 (10) 3481246.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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