C.R. Bard Inc — SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
⚠️ 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
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 17, 2025
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.
What's affected?
- Product
- SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
- Brand
- C.R. Bard Inc
- Lot code
- NGJX4320
Additional details
Lot# NGJX4320
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3670.
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