4,300 SureStep Foley Tray System Bardex I.C. Complete Care catheter tray units are recalled nationwide by C.R. Bard. The trays may contain incorrect inserts, creating a risk of infection or an allergic reaction. Healthcare providers and patients should stop using the device and follow Bard’s 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
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Foley catheter trays are used in medical procedures to prepare and support catheter placement. The SureStep tray line includes infection-control features intended for sterile use.
If inserts are incorrect, the tray could misrepresent material properties, potentially exposing latex or silicone materials and coatings that do not meet stated expectations. This misrepresentation can lead to infection or allergic reactions.
This recall is not described as part of a broader industry pattern in the provided data.
The recall could affect patient safety in clinical settings and may require facilities to audit stock and training to prevent infections.
FDA enforcement page Z-2589-2025 and Bard recall communications provide official identification details.
Recall processing and replacement or refunds follow Bard's recall timeline; typically weeks to months depending on facility stock.
Retain recall letter, document serial/model numbers, dates of procurement, and communications with Bard or suppliers.
Model: REF: A303316A. Sold nationwide in the United States. Quantity: 4,300 units. Price: Unknown. Brand: C.R. Bard. Product family: SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray.
No injuries or incidents have been reported.
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