C.R. Bard recalled 3,670 Foley catheter trays on July 17, 2025, due to incorrect inserts. Users may confuse materials, leading to allergies or infections. Healthcare providers and patients must stop using these trays immediately.
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
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The recall involves the SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF: A942216. The trays were distributed nationwide across multiple states including NC, FL, NY, and CA. They were not priced in the recall notice.
The trays contain incorrect inserts that may mislead users about the materials. Users could mistakenly believe they are using silicone instead of natural rubber latex, potentially leading to infections or allergic reactions.
There are no known reported incidents or injuries associated with this recall. The hazard level is classified as high due to the potential for allergic reactions.
Stop using the affected trays immediately. Follow the manufacturer's recall instructions and contact C.R. Bard Inc or your healthcare provider for further instructions.
For more information, call C.R. Bard Inc. or visit their website. Additional recall information is available at the FDA's website.
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