C.R. Bard Inc issued a recall for 4,300 Foley catheter trays on July 17, 2025. Incorrect inserts lead to potential allergic reactions and infection risk. Healthcare providers and patients must stop using the device 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 Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A. The trays were distributed nationwide in the U.S. and are associated with lot number NGJY3685.
The Foley catheter trays contain incorrect inserts that may mislead users regarding their materials. This may result in allergic reactions or infections.
As of now, there are no specific reports of injuries or deaths related to this recall. The potential for allergic reactions remains a concern.
Stop using the product immediately. Follow the recall instructions from C.R. Bard Inc and contact your healthcare provider for further instructions.
For more details, contact C.R. Bard Inc or visit the FDA website for recall instructions at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2590-2025.
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