SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
Reported: September 24, 2025 Initiated: July 17, 2025 #Z-2590-2025
Product Description
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
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
Details
- Recalling Firm
- C.R. Bard Inc
- Units Affected
- 4,300
- Distribution
- US Nationwide distribution including in the states of NC, FL, NY, MA, MN, TX, CA, OH, MI, WA, NJ, IL, ID, SC, IN, OK, OR, AL, VA, HI, MO, MS, MD, AZ, KY, GA, IA, CO, NM, PA, ME, UT, NE.
- Location
- Covington, GA
Frequently Asked Questions
What product was recalled? ▼
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A. Recalled by C.R. Bard Inc. Units affected: 4,300.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 24, 2025. Severity: Moderate. Recall number: Z-2590-2025.
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