Foley Catheter Tray System Recalled Due to Incorrect Component Materials
C.R. Bard is recalling 4,300 SureStep Foley Tray System units with incorrect catheter inserts that may mislead users about material type and antimicrobial coating, risking allergic reactions and infections.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves allergen mislabeling of a common allergen (latex) where patients with latex allergy could be exposed without knowledge, creating risk of allergic reaction. No illnesses have been reported, but the hazard is material and direct.
Plain-English summary
C.R. Bard Inc is recalling 4,300 units of the SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray (REF: A303414A, Lot# NGJY3685). The recalled trays contain catheter inserts with incorrect material types that do not match the product labeling.
The incorrect inserts create confusion about what material patients will receive. Users may believe they are receiving silicone inserts when the tray actually contains natural rubber latex, or vice versa. Users may also expect silicone hydrogel inserts with antimicrobial coating when receiving silicone hydrogel without antimicrobial coating, or expect latex with infection control when receiving silicone hydrogel without antimicrobial protection.
This mislabeling poses risks including allergic reaction in patients with latex allergy who receive latex inserts thinking they are getting silicone, and infection risk in patients expecting antimicrobial coating that is not present. Healthcare providers should identify affected trays, verify actual insert materials, and ensure patient matching based on allergies and clinical needs.
The recalled product
- Product
- SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
- Manufacturer
- C.R. Bard Inc
- Hazard
- allergen-latex
- infection-risk
- mis-labeling
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 (1)
- Lot# NGJY3685
Distribution
Distributed nationwide across the United States.
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