The Recall Desk

FDA (Devices) recall action 88499

C.R. Bard Inc recalled 21 products on 2021-09-29

The FDA (Devices) publishes a recall like this one as 21 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 21 pages.

Products
21
Announced
2021-09-29
Critical
0
Units
154,790

Why these products were recalled

There is potential for packaging defects that may impact the sterile barrier.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–21 of 21

  • HighFDA (Devices)··2021-09-29

    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.

    Product
    Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    SureStep Foley Tray Recall: Packaging Defects May Compromise Sterile Barrier

    C.R. Bard Inc is recalling SureStep Foley Trays (Catalog A902616) due to packaging defects that may compromise the sterile barrier. Affected units were distributed nationwide.

    Product
    Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    Foley Catheter Tray Recalled Due to Potential Packaging Defects

    C.R. Bard is recalling 2,660 units of SureStep Foley Catheter Trays nationwide due to potential packaging defects that may impact the sterile barrier.

    Product
    Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    C.R. Bard SureStep Foley Tray Recalled for Packaging Defect Risk

    C.R. Bard is recalling SureStep Foley Tray units due to potential packaging defects that may compromise the sterile barrier. The recalled product was distributed nationwide in the United States.

    Product
    Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    C.R. Bard Foley Catheter Trays Recalled for Packaging Defects

    C.R. Bard is recalling 420 units of Foley catheter care trays nationwide due to potential packaging defects that may impact the sterile barrier.

    Product
    Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    C.R. Bard Foley Catheter Tray Recall Due to Packaging Defects

    C.R. Bard Inc is recalling the SureStep Foley Tray (Lot NGEVX108) due to potential packaging defects that may affect the sterile barrier. The product was distributed nationwide.

    Product
    Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    C.R. Bard Foley Catheter Tray recalled for potential packaging defects

    C.R. Bard Inc is recalling approximately 29,890 units of Foley catheter trays due to potential packaging defects that may compromise the sterile barrier. No illnesses or injuries have been reported.

    Product
    Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    Foley Catheter Drainage Tray System Packaging Defect Recall

    C.R. Bard Inc is recalling a Foley catheter tray system due to potential packaging defects that may compromise the sterile barrier, affecting 1,760 units distributed nationwide.

    Product
    Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    C.R. Bard Foley Catheter Care Kits Recalled for Potential Sterile Barrier Defect

    C.R. Bard Inc is recalling Foley catheter care kits (catalog A303416A) because potential packaging defects could compromise the sterile barrier. Approximately 6,440 units were distributed nationwide.

    Product
    Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    C.R. Bard Foley Catheter Trays Recalled for Sterile Packaging Defects

    C.R. Bard is recalling 3,980 units of Foley catheter supply kits due to potential packaging defects that may compromise the sterile barrier. No illnesses have been reported.

    Product
    Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    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.

    Product
    Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    C.R. Bard Foley Catheter Tray Recalled for Potential Packaging Defect

    C.R. Bard is recalling 11,600 units of its Foley catheter tray assembly nationwide due to potential packaging defects that may compromise the sterile barrier.

    Product
    Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    C.R. Bard Foley Catheter Kits Recalled for Potential Sterile Barrier Defects

    C.R. Bard is recalling 960 units of Foley Tray catheter kits (lot NGFR0101) due to potential packaging defects that may compromise the sterile barrier.

    Product
    Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    C.R. Bard SureStep Foley Catheter Tray Sterile Barrier Defect Recall

    C.R. Bard is recalling 5,950 SureStep Foley Tray kits nationwide due to potential packaging defects that may impact the sterile barrier.

    Product
    Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    Foley Catheter Tray Recalled for Packaging Defects Affecting Sterile Barrier

    C.R. Bard Inc is recalling SureStep Foley Catheter Trays due to potential packaging defects that may compromise the sterile barrier. The affected lot includes 1140 units distributed nationwide.

    Product
    Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    C.R. Bard Foley Tray Recalled for Potential Sterile Barrier Packaging Defects

    C.R. Bard Inc is recalling Foley Tray kits nationwide due to potential packaging defects that may compromise the sterile barrier. The product was distributed throughout the United States.

    Product
    Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    C.R. Bard SureStep Foley Catheter Tray Recalled for Sterile Barrier Defect

    C.R. Bard Inc is recalling SureStep Foley Catheter Trays due to potential packaging defects that may compromise the sterile barrier. The recall affects 33,380 units distributed nationwide.

    Product
    Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    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.

    Product
    Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    C.R. Bard Foley Catheter Tray Recalled for Packaging Defects

    C.R. Bard is recalling a Foley catheter tray system due to packaging defects that may compromise the sterile barrier. The recall affects 8,170 units distributed nationwide.

    Product
    Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    C.R. Bard Foley Tray and Drainage Bag Recalled for Packaging Defects

    C.R. Bard is recalling 11,780 Foley Tray units nationwide due to potential packaging defects that may compromise the sterile barrier.

    Product
    Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-29

    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.

    Product
    Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization Device
    Category
    Distribution
    0 states