C.R. Bard Foley Catheter Kit Recall: Packaging Sterility Defect
C.R. Bard is recalling Foley catheter kits due to packaging defects that may compromise the sterile barrier. No illnesses have been reported.
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 with a risk-of-harm hazard (packaging defect compromising sterile barrier, which could lead to infection), but no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
C.R. Bard Inc is recalling Foley catheter kits sold under model Catalog A300318A, which includes the SureStep Foley Tray, Bardex I.C., Complete Care Drainage Bag, and StatLock Stabilization Device. The recall affects 350 units distributed nationwide in the United States.
The kits are being recalled due to potential packaging defects that may compromise the sterile barrier. A compromised sterile barrier could allow bacterial contamination of the catheter system.
No illnesses or injuries have been reported. If you have received or are using one of these kits, do not use the product. Contact C.R. Bard Inc to arrange return of the affected units. Healthcare facilities should check their inventory using lot number NGEVX106 and contact the manufacturer for replacement or further guidance.
The recalled product
- Product
- Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, 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 A300318A
- Lot NGEVX106
- UDI (01)00801741073748(17)201228(10)
Distribution
Distributed nationwide across the United States.
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