SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
Summary
The FDA issued a Class II for SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley by C.R. Bard Inc. 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 contr.
Details
Source
Device Recall
External ID
Z-2590-2025
Action Date
2025-09-24
Status
Ongoing
Category
device
Product Description
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
Lot/Code Info: Lot# NGJY3685
Quantity Affected: 4,300
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-17
Company
Covington, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 133 device recalls issued in the same week, part of 413 device-related FDA actions this month.
C.R. Bard Inc has 78 FDA actions in our database, including 64 recalls and 14 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (C.R. Bard Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does C.R. Bard Inc have FDA actions?
C.R. Bard Inc has 78 FDA actions in our database, including 64 recalls and 14 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2590-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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