CLASS I Device recall · Reported 17 Oct 2012 · FDA Enforcement Report
Baxter Clearlink System Buretrol Solution Set recalled
Baxter Healthcare is recalling Baxter Clearlink System Buretrol Solution Set, 115" 9 m) with Clearlink Burette, distributed nationwide in the US. The recall was initiated on 7 Sep 2012 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0014-2013
- FDA event ID
- 63059
- Recalling firm
- Baxter Healthcare, Round Lake, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 7 Sep 2012
- FDA classified
- 9 Oct 2012
- Reported
- 17 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 7 Sep 2012 | Recall initiated by company | |
| 9 Oct 2012 | Classified by FDA | +32 days |
| 17 Oct 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber); 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.
Where it was distributed
Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.
Questions about this recall
Is Baxter Clearlink System Buretrol Solution Set, 115" 9 m) with Clearlink Burette recalled?
Yes. Baxter Healthcare recalled Baxter Clearlink System Buretrol Solution Set, 115" 9 m) with Clearlink Burette on 7 Sep 2012. The recall is Class I and its status is Terminated. Recall number Z-0014-2013.
Why was it recalled?
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.
Which lots are affected?
product code 2C8819, all lots
Where was it sold?
Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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