C.R. Bard recalls SureStep Foley Tray System with incorrect inserts that may cause infection due to material mix-ups. Affected units have REF: A303316A and Lot#NGJX6399.
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 SureStep Foley Tray Systems with incorrect inserts that could cause infections. Using these trays might lead to allergic reactions or infections because the materials are mislabeled.
The trays have incorrect inserts that may be natural rubber latex instead of silicone, or silicone with antimicrobial coating instead of natural latex. This mix-up can cause allergic reactions or infections.
Healthcare workers and patients using the SureStep Foley Tray System with REF: A303316A and Lot#NGJX6399 are affected. Those with latex allergies or infection risks are most at risk.
Check for the model reference A303316A and lot number NGJX6399 on the tray. The product is sold under C.R. Bard's SureStep Foley Tray System.
Verify the insert material matches the label: it should be silicone hydrogel with antimicrobial coating, not natural rubber latex.
The model reference is A303316A with lot number NGJX6399.
The recall states it may cause infection or allergic reactions, but not serious injury in normal use.
Look for the model reference A303316A and lot number NGJX6399 on the tray.
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-2589-2025 — C.R. Bard C.R. Bard Hello, I own a C.R. Bard that is covered by recall Z-2589-2025 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.
