C.R. Bard recalls SureStep Foley Trays with potential packaging defects that could compromise sterile barrier. Affected units include specific lots and models sold from 2012-2021. Consumers should check product details to determine eligibility.
There is potential for packaging defects that may impact the sterile barrier.
C.R. Bard is recalling SureStep Foley Trays that may have packaging defects risking the sterile barrier. This could lead to infections if the tray is not properly sterilized during medical procedures.
Packaging defects might allow contaminants to enter the sterile barrier, potentially causing infections during medical procedures. The sterile barrier is critical for maintaining aseptic conditions in medical treatments.
Healthcare professionals using these medical devices are most at risk. Patients receiving care with the recalled trays could be affected if the sterile barrier is compromised.
Check for the model number Catalog A319516AM on the product. Affected lots include NGFS1691, NGFR3282, and NGFR4423 with specific UDI codes. The recall was expanded on October 8, 2021.
Identify the model number and lot numbers to confirm if your product is affected.
The recall is due to potential packaging defects that could impact the sterile barrier, increasing infection risk during medical procedures.
Check the model number and lot numbers to see if your product is affected. If it is, contact C.R. Bard for further instructions.
The recall was expanded on October 8, 2021, but no specific deadline is mentioned for action.
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-2538-2021 — C.R. Bard C.R. Bard Hello, I own a C.R. Bard that is covered by recall Z-2538-2021 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.
