Bard recalls SureStep Foley Tray (Catalog A800365) due to potential packaging defects that could compromise sterile barrier integrity. Affected units include specific lots and UDI numbers listed in the recall notice.
There is potential for packaging defects that may impact the sterile barrier.
Bard is recalling SureStep Foley Trays with a specific catalog number and lot codes because packaging defects might break the sterile barrier. This could lead to infections if the tray isn't properly sterilized during medical procedures.
Packaging defects might cause the sterile barrier to break during handling or storage. This could lead to contamination of the tray, increasing infection risk during medical procedures if the tray isn't properly sterilized.
Healthcare professionals using the SureStep Foley Tray for medical procedures are most at risk. Patients receiving catheter care with this specific model could be affected if the sterile barrier is compromised.
Check for the catalog number A800365 on the tray. Affected units include specific lot codes: NGFR3131, NGFR3295, NGFR4413, NGFR4599, and NGFS3150 with the listed UDI numbers.
Look for the catalog number A800365 and specific lot codes listed in the recall notice.
The recalled product is the SureStep Foley Tray with catalog number A800365.
Affected lots include NGFR3131, NGFR3295, NGFR4413, NGFR4599, and NGFS3150 with specific UDI numbers.
Packaging defects could compromise the sterile barrier, potentially leading to contamination and infection risk during medical procedures if the tray isn't properly sterilized.
We’ve drafted a message you can send Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-2532-2021 — Bard Bard Hello, I own a Bard that is covered by recall Z-2532-2021 from 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.
