Recall Z-0015-2013— Baxter Healthcare Corp.
Class I · Terminated
Class I FDA medical device recall by Baxter Healthcare Corp., initiated 2012-09-07, terminated 2017-12-29. It names one FDA 510(k) clearance: K984381. Product: 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: 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..
- Recalling firm
- Baxter Healthcare Corp.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2012-09-07
- Terminated
- 2017-12-29
- Firm location
- Round Lake, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.