Bardex Foley catheter trays recalled over inserts describing the wrong material
SureStep Foley Tray Systems, REF A303316A lot NGJX6399, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating, risking infection or allergic reaction.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a latex or coating mismatch that may cause infection or allergic reaction is a potential harm and no injuries are reported.
Plain-English summary
The SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF A303316A, lot NGJX6399, is being recalled. The recall covers 4,300 units distributed across more than 15 states.
The Foley catheter trays have incorrect inserts. A user may believe the catheter is silicone when it is natural rubber latex; or natural rubber latex with an infection control coating when it is silicone hydrogel with an antimicrobial coating; or natural latex with infection control when it is silicone hydrogel coated without an antimicrobial coating. The manufacturer states this may cause infection and/or a local and/or systemic allergic reaction. The FDA classified the action as Class II.
Hospitals holding this lot should quarantine it and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
- Manufacturer
- C.R. Bard Inc
- Affected units
- 4,300
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot#NGJX6399
Distribution
Part of a larger recall action
This product is one of 3 recalled by C.R. Bard Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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