FDA recall Z-2591-2025

C.R. Bard Inc · Class II · device

Product

SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216

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

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.

Key facts

Status
Ongoing
Initiation date
2025-07-17
Report date
2025-09-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Covington, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2591-2025