C.R. Bard recalls SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray (REF: A303414A) due to incorrect inserts that may cause infection or allergic reactions.
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
C.R. Bard is recalling a specific model of Foley catheter tray because its inserts are made of the wrong material. This could lead to infections or allergic reactions if the user mistakes the inserts for different types of materials.
The inserts in this tray are incorrectly labeled. Users might think they are silicone, natural rubber latex, or silicone hydrogel with antimicrobial coating, but they are actually a different material. This mismatch could cause infections or allergic reactions.
Healthcare workers and patients using the SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray (REF: A303414A) are affected. Those with latex allergies or infection risks are most at risk.
Check for the model name 'SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray' and the reference number A303414A. The lot number NGJY3685 is also associated with this recall.
Verify the material of the inserts to ensure they match the correct specifications for infection control.
The recalled model is SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray with reference number A303414A.
Using the wrong inserts could cause infections or allergic reactions due to incorrect material composition.
The recall record does not mention a specific fix or remedy for the inserts.
We’ve drafted a message you can send C.R. Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-2590-2025 — C.R. Bard C.R. Bard Hello, I own a C.R. Bard that is covered by recall Z-2590-2025 from C.R. Bard. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
