SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot#NGJX6399
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- C.R. Bard Inc
- Reason for Recall:
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Product Codes/Lot Numbers:
Lot#NGJX6399
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2589-2025
Related Recalls
Class I - Dangerous
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Class I - Dangerous
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Class I - Dangerous
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.