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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 8 of 8 Results
510(K) Number: K040658
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Product Description
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Recall
Class
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FDA Recall
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SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A30... 2 09/18/2025 FEI # 1018233
C.R. Bard Inc
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: ... 2 09/18/2025 FEI # 1018233
C.R. Bard Inc
SureStep Foley Tray System BARD® Lubri-Sil Foley Catheter Tray, REF: A942216 2 09/18/2025 FEI # 1018233
C.R. Bard Inc
Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Comp... 2 06/18/2024 FEI # 1018233
C.R. Bard Inc
Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabili... 2 09/23/2021 FEI # 1018233
C.R. Bard Inc
Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabil... 2 09/23/2021 FEI # 1018233
C.R. Bard Inc
Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sens... 2 09/23/2021 FEI # 1018233
C.R. Bard Inc
SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/o... 2 05/13/2020 FEI # 1018233
C.R. Bard Inc
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