Foley Catheter Tray Packaging Defect Poses Sterile Barrier Risk
C.R. Bard Inc is recalling a Foley catheter tray due to potential packaging defects that may compromise the sterile barrier. Approximately 1,710 units were distributed nationwide.
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 involving a risk-of-harm product (sterile barrier defect could enable contamination). No illnesses or injuries are reported. Per the rubric, this qualifies as High (3) severity—a risk-of-harm product where injury has not yet been reported.
Plain-English summary
C.R. Bard Inc is recalling Catalog A897514 SureStep Foley Trays with SureStep Silicone Drainage Bags and StatLock Stabilization Devices. The FDA has classified this as a Class II recall. According to the recall notice, there is potential for packaging defects that may impact the sterile barrier on these medical devices.
The recall affects approximately 1,710 units that were distributed nationwide in the United States. The specific lot number involved is NGFR2808, with UDI (01)00801741104510(17)201228(10).
Patients and healthcare providers who have received these devices are advised to stop using affected units and contact C.R. Bard Inc for instructions on return or replacement.
The recalled product
- Product
- Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device
- Manufacturer
- C.R. Bard Inc
- Hazard
- sterile-barrier-defect
- packaging-defect
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 A897514
- Lot NGFR2808
- UDI (01)00801741104510(17)201228(10)
Distribution
Distributed nationwide across the United States.
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