C.R. Bard Recalls Foley Catheter Trays Over Allergy Risk
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.
Quick Facts at a Glance
Recall Date
July 17, 2025
Hazard Level
HIGH
Brand
C.R. Bard
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL
Hazard Information
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
What You Should Do
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
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Product Details
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 Hazard
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.
What to Do
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.
Contact Information
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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