FDAFDA · Food and drugs·Recall number Z-0015-2013
Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Published October 17, 2012 · Recall initiated: September 7, 2012
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
Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corp.
- Distributor
- Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.
- Lot
- product code 2H8819, all lots
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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