HIGH

C.R. Bard Recalls Foley Catheter Tray Over Infection Risk

C.R. Bard Inc issued a recall for 4,300 Foley catheter trays on July 17, 2025. Incorrect inserts lead to potential allergic reactions and infection risk. Healthcare providers and patients must stop using the device immediately.

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact C.R. Bard Inc or your healthcare provider for instructions. Notification method: Letter

Product Details

The recall involves the SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A. The trays were distributed nationwide in the U.S. and are associated with lot number NGJY3685.

The Hazard

The Foley catheter trays contain incorrect inserts that may mislead users regarding their materials. This may result in allergic reactions or infections.

Reported Incidents

As of now, there are no specific reports of injuries or deaths related to this recall. The potential for allergic reactions remains a concern.

What to Do

Stop using the product immediately. Follow the recall instructions from C.R. Bard Inc and contact your healthcare provider for further instructions.

Contact Information

For more details, contact C.R. Bard Inc or visit the FDA website for recall instructions at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2590-2025.

Key Facts

  • Recall date: July 17, 2025
  • Total units recalled: 4,300
  • Potential risk of infection and allergic reactions
  • Sold nationwide in the U.S.
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot# NGJY3685
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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