C.R. Bard recalls SureStep Foley Tray System with incorrect inserts that may cause allergic reactions. Affected units have specific model and lot numbers. Consumers should contact Bard for details.
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 allergic reactions. Using these trays might lead to infections or allergic reactions if the material is misidentified.
The trays have incorrect inserts that may be mistaken for natural rubber latex or silicone. This confusion could lead to allergic reactions or infections if the wrong material is used.
Healthcare professionals and patients using the SureStep Foley Tray System are at risk. Those with latex allergies are most vulnerable to reactions.
Check for the model reference A944216 and lot number NGJX4320 on the tray. The product was sold with these specific identifiers.
Look for the model reference A944216 and lot number NGJX4320 on the tray.
Using the recalled trays may cause allergic reactions or infections due to incorrect inserts that could be mistaken for natural rubber latex.
Check for model reference A944216 and lot number NGJX4320 on the tray.
The recall does not specify a remedy, so contact C.R. Bard directly for further instructions.
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-2591-2025 — C.R. Bard C.R. Bard Hello, I own a C.R. Bard that is covered by recall Z-2591-2025 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.
