C.R. Bard recalled 4,300 Foley catheter trays on July 17, 2025. Incorrect inserts may lead users to misidentify materials, increasing infection and allergic reaction risks. Patients and healthcare providers must stop using the trays immediately and follow recall instructions.
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact C.R. Bard Inc or your healthcare provider for instructions. Notification method: Letter
The recall involves the SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A. It was distributed nationwide in states including California, Florida, and New York. The trays were sold through various healthcare providers.
The trays contain incorrect inserts that can mislead users about the material composition. Misidentification can lead to infections or allergic reactions, posing serious health risks.
As of now, no specific incidents or injuries have been reported. However, the nature of the hazard poses a high risk of allergic reactions and infections.
Stop using the Foley catheter trays immediately. Patients and healthcare providers should contact C.R. Bard Inc or their healthcare provider for further instructions and follow the recall process.
For more information, contact C.R. Bard Inc at the details provided in the recall notification letter. Visit the FDA website for additional details.
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