CR Bard recalled 3,670 SureStep Foley Tray System A942216 Foley Catheter Trays nationwide after discovering incorrect inserts. Mislabeling could cause infection or allergic reactions. Healthcare providers should stop using the device immediately and follow recall instructions from the manufacturer.
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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Foley catheter trays are used in clinical settings to organize and prepare catheter insertions. The SureStep Tray System is designed for efficient workflows in patient care.
Incorrect inserts create a material mismatch risk. If latex is present where silicone is expected, patients may suffer infections or allergic reactions.
This recall is not described as part of a broader industry pattern in the release.
Hospitals and clinics may need to halt use of affected trays, replace stock, and refabricate procedures to avoid infection or latex allergy reactions.
CR Bard recall communications and FDA enforcement page; contact the manufacturer for instructions
Typically 4-8 weeks for refunds or replacements in recalls; exact timelines vary by facility and replacement stock availability
Keep recall notices, correspondence with manufacturer, batch/lot numbers, and inventory segregation records as part of the incident file
Model: A942216 Origin: United States Sold: Nationwide distribution in the U.S. Quantity: 3,670 units Brand: CR Bard Product: SureStep Foley Tray System, Lubri-Sil Foley Catheter Tray, REF A942216 Status: Active recall as of 2025-09-24 Notes: Specific dates of sale not provided; recall distributed nationwide.
No injuries or incidents have been reported.
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