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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary action for a mechanical defect (chamber separation) with no reported injuries or illnesses in the source text, fitting the Moderate criteria for low-risk or precautionary recalls.
Plain-English summary
Baxter Healthcare Corporation is voluntarily recalling specific lots of Buretrol Solution Sets. The recall involves product codes 2C7564, 2C8864, and 2H8864. The affected units are 105-inch (2.7 m) solution sets with a 150 mL burette, drip chamber filter valve, and three injection sites.
The recall was issued due to complaints regarding separation between the burette chamber and the drip chamber. The product is indicated for the administration of fluids from a container into the patient's vascular system through a vascular access device. The fluid path is sterile and nonpyrogenic.
The affected product was distributed nationwide. Baxter Healthcare is the recalling firm. The source text does not specify the exact number of affected units or the specific dates of distribution.
The recalled product
- Product
- ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male Luer Lock Adapter with***Retractable Collar***Fluid path is Sterile, Nonpyrogenic***Indications for Use: For the administration of fluids from a container into…
- Manufacturer
- Baxter Healthcare Corp
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 234,196
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)
- 2C7564- Buretrol Solution Set with 150mL INTERLINK 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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