Bard recalls specific 0.014" Crossing Support Catheters due to potential bacterial endotoxin cross-contamination risk in packaging. Affected units may pose clinical contamination risks during procedures.
Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.
Bard is recalling a specific type of vascular catheter because packaging hoops might contain bacterial endotoxins that could cross-contaminate during medical procedures. This could theoretically lead to infections in clinical settings if the catheter is used improperly.
The catheter packaging hoops may contain detectable bacterial endotoxins. If these endotoxins cross-contaminate during medical procedures, they could theoretically introduce infection risks in clinical settings.
Healthcare professionals using the specific catheter model for medical procedures are most at risk. Patients receiving procedures with this catheter could potentially face infection risks.
Check for the model: 0.014" Crossing Support Catheter, 150 cm, REF SK15014. The lot number VTBZ0193 is associated with this recall.
Verify the model number and lot number on the catheter packaging to confirm if it's affected.
The recall states the catheter itself has acceptable endotoxin levels, but packaging hoops may contain detectable endotoxins that could cross-contaminate during procedures.
The recall does not specify a remedy, so check the product details to confirm if it's affected before taking any action.
The recall indicates potential cross-contamination risk but does not mention serious injury or death. The hazard level is low risk.
We’ve drafted a message you can send Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-1803-2018 — Bard Bard Hello, I own a Bard that is covered by recall Z-1803-2018 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.
