Bard SureStep Foley Tray System Recalled for Potential Sample Port Leaks
Bard Medical Division is recalling 450 units of SureStep Foley Tray Systems because the sample ports may leak urine.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional defect (leaking) that could compromise infection control or hygiene, but the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bard Medical Division is recalling 450 units of the BARD SureStep Foley Tray System, specifically the Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. The affected products are sterile and intended for the drainage, collection, or measurement of urine.
The recall is due to a defect in the vented sample ports, which may have an increased likelihood of leaking urine. The specific product code is A319418AM, lot number NGCT1929, with an expiration date of 11/30/2018.
The affected units were distributed nationwide to Kentucky, Nebraska, Georgia, Florida, Mississippi, Indiana, Illinois, Virginia, Oklahoma, Texas, New Mexico, Pennsylvania, California, and Nevada. Healthcare facilities and consumers should stop using the affected products and contact Bard Medical Division for further instructions.
The recalled product
- Product
- BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.
- Manufacturer
- Bard Medical Division
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 450
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Code A319418AM
- Lot NGCT1929
- Exp. Date 11/30/2018
Distribution
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