SureStep Foley Catheter Tray Recalled for Sterile Barrier Packaging Defect
C.R. Bard Inc is recalling approximately 4830 SureStep Foley catheter trays due to potential packaging defects that could compromise the sterile barrier.
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: FDA Class II medical device recall for a risk-of-harm product. The potential sterile barrier defect on a catheterization device poses patient safety risk, but no injuries or illnesses have been reported.
Plain-English summary
C.R. Bard Inc is recalling SureStep Foley Tray (Catalog A902416) due to potential packaging defects that may impact the sterile barrier. The recalled product is a Foley catheter tray containing a silicone urine meter and StatLock stabilization device. Approximately 4830 units have been distributed nationwide.
The packaging defect may compromise the sterile barrier integrity of the product. A compromised sterile barrier could allow contamination, potentially affecting patient safety during catheterization procedures.
Affected units are identified by Lot NGFR4567, with UDI (01)00801741074042(17)201228(10). Patients or healthcare providers who have received this product should contact their healthcare provider or C.R. Bard Inc for guidance on whether their units are affected.
The recalled product
- Product
- Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization Device
- Manufacturer
- C.R. Bard Inc
- Hazard
- sterile-barrier-defect
- contamination-risk
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 (3)
- Catalog A902416
- Lot NGFR4567
- UDI (01)00801741074042(17)201228(10)
Distribution
Distributed nationwide across the United States.
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