HIGH

C.R. Bard Recalls Foley Catheter Trays Over Allergy Risk

C.R. Bard recalled 3,670 Foley catheter trays on July 17, 2025, due to incorrect inserts. Users may confuse materials, leading to allergies or infections. Healthcare providers and patients must stop using these trays immediately.

Quick Facts at a Glance

Recall Date
July 17, 2025
Hazard Level
HIGH
Brand
C.R. Bard
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

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

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Product Details

The recall involves the SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF: A942216. The trays were distributed nationwide across multiple states including NC, FL, NY, and CA. They were not priced in the recall notice.

The Hazard

The trays contain incorrect inserts that may mislead users about the materials. Users could mistakenly believe they are using silicone instead of natural rubber latex, potentially leading to infections or allergic reactions.

Reported Incidents

There are no known reported incidents or injuries associated with this recall. The hazard level is classified as high due to the potential for allergic reactions.

What to Do

Stop using the affected trays immediately. Follow the manufacturer's recall instructions and contact C.R. Bard Inc or your healthcare provider for further instructions.

Contact Information

For more information, call C.R. Bard Inc. or visit their website. Additional recall information is available at the FDA's website.

Key Facts

  • Recall date: July 17, 2025
  • Quantity recalled: 3,670 units
  • Distribution: Nationwide in the US
  • Hazard level: High

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
A942216
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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