Z-0015-2013 Class I Terminated
FDA device recall Z-0015-2013 was initiated by Baxter Healthcare Corp. on Sep 7, 2012 and is designated Class I. Reason for recall: 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 recall status is terminated (terminated Dec 29, 2017). Affected quantity: 488,504 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 17, 2012
- Initiation Date
- Sep 7, 2012
- Termination Date
- Dec 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 488,504 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.
Code Information
product code 2H8819, all lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0015-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026