SureStep Foley Catheter Tray Recalled for Packaging Defects
C.R. Bard is recalling 18,060 units of SureStep Foley Catheter Trays due to potential packaging defects that may compromise the sterile barrier. No illnesses or injuries 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 recall for potential packaging defect with no reported illnesses or injuries. Per severity rubric, risk-of-harm products where injury has not yet been reported score 3.
Plain-English summary
C.R. Bard Inc. is recalling the SureStep Foley Catheter Tray (Catalog A800365) due to potential packaging defects. Approximately 18,060 units have been distributed nationwide across five affected lots: NGFR3131, NGFR3295, NGFR4413, NGFR4599, and NGFS3150.
The defect involves the packaging's ability to maintain sterility. While no illnesses or injuries have been reported to date, a compromised sterile barrier could potentially allow contamination of the catheter tray.
Healthcare providers, distributors, and facilities that have received this product should verify their inventory against the affected lot numbers and UDI codes provided. Contact C.R. Bard for information regarding affected inventory in your possession.
The recalled product
- Product
- Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
- Manufacturer
- C.R. Bard Inc
- Hazard
- packaging-defect
- sterile-barrier
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 (7)
- Catalog A800365
- Lots: NGFR3131
- UDI (01)00801741073960(17)201220(10)
- NGFR3295
- NGFR4413
- NGFR4599
- and NGFS3150 UDI (01)00801741073960(17)201220(10)
Distribution
Distributed nationwide across the United States.
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