C.R. Bard Inc. recalls 4,300 SureStep Foley Tray System Lubri-Sil I.C. Complete Care infection control Foley catheter trays nationwide in the United States. The trays may contain incorrect inserts that misrepresent material composition. The mismatch could trigger infections or allergic reactions. Health care providers should stop use and follow recall instructions immediately.
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
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact C.R. Bard Inc or your healthcare provider for instructions. Notification method: Letter
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Foley catheter trays are used in hospitals for sterile preparation of catheters. They ensure protected insertion workflows and infection control.
Mismatched inserts can misrepresent material properties, potentially causing infection or allergic reactions when used in catheter procedures.
This recall is not identified as part of a broader industry pattern in the provided data.
Represents a high-risk scenario for hospital procurement and patient safety, with urgent need for facility action and proper documentation.
Product labels and packing slips; recall letter from Bard; FDA enforcement page
Replacement or refund timelines not specified; expect guidance from Bard or FDA notices within weeks
Keep copy of the recall letter, batch/lot numbers, and any replacements or refunds.
Model: Lot# NGJY3685. Quantity: 4,300 units. Distribution: US nationwide. REF: A303414A. Category: Foley catheter trays used in infection control. Manufacturer: C.R. Bard. Recall Date: 2025-07-17. Status: ACTIVE.
No injuries or incidents have been reported in the available recall notice.
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4,300 SureStep Foley Tray System Bardex I.C. Complete Care catheter tray units are recalled nationwide by C.R. Bard. The trays may contain incorrect inserts, creating a risk of infection or an allergic reaction. Healthcare providers and patients should stop using the device and follow Bard’s recall instructions.