Baxter Recalls Buretrol Solution Sets Due to Chamber Separation
Baxter Healthcare is voluntarily recalling specific lots of Buretrol Solution Sets because the burette chamber may separate from the drip chamber.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (chamber separation) that poses a risk of harm to patients, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Baxter Healthcare Corporation is voluntarily recalling specific lots of Buretrol Solution Set products. The recall is being issued due to complaints regarding separation between the burette chamber and the drip chamber.
The affected product codes are 2C7564, 2C8864, and 2H8864. The recall covers 11,184 units that were distributed nationwide. Specific lot numbers for the 2H8864 code include DR13E10011, DR13E10029, DR13E11019, DR14A13013, and DR14C08043.
These solution sets are used for the administration of fluids from a container into a patient's vascular system. Users should check their inventory for the affected product codes and lot numbers and stop using any units that match the recall criteria.
The recalled product
- Product
- ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve 3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic.***Indications for Use: For the administration of fluids from a
- Manufacturer
- Baxter Healthcare Corp
- Affected units
- 11,184
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 2H8864- Non-DEHP Buretrol Solution Set
- 150 mL CLEARLINK Burette
- lots: DR13E10011 DR13E10029 DR13E11019 DR14A13013 DR14C08043
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Baxter Healthcare Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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