The Recall Desk
ModerateFDA (Devices)·Z-2613-2014·Announced 2014-09-17

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

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
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.

See all 3 products in this recall →