FDA Enforcement
Class II
Ongoing
SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
Recall: Z-2591-2025
·
Reported September 24, 2025
Enforcement
- Recall Number
- Z-2591-2025
- Event ID
- 97273
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- C.R. Bard Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 24, 2025
- Initiation Date
- July 17, 2025
- Classification Date
- September 18, 2025
- Address
- 8195 Industrial Blvd Ne, N/A, Covington, GA, 30014-1497, United States
Description
SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
Reason
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
Code Info
Lot# NGJX4320
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.
Quantity
3670