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 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 risk-of-harm product where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is voluntarily recalling specific lots of Buretrol Solution Sets. 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 recalled product is a 105-inch (2.7 m) solution set with a 150 mL burette, drip chamber filter valve, and three Luer activated valves. The fluid path is sterile and nonpyrogenic. The product is indicated for the administration of fluids from a container into the patient's vascular system through a vascular access device.
The recall involves 107,232 units distributed nationwide. Specific lot numbers are listed in the agency's recall record. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- ***Baxter***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 cont
- Manufacturer
- Baxter Healthcare Corp
- Category
- Medical Device — Infusion Sets
- Affected units
- 107,232
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 (1)
- 2C8864- Buretrol Solution Set with 150mL CLEARLINK Burette
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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