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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

C.R. Bard Inc: There is potential for packaging defects that may impact the sterile barrier.

Agency Publication Date: September 23, 2021
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Affected Products

Product: Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device

Catalog A303416A, Lot NGFS1844, UDI (01)00801741073823(17)201228(10); NGFS1845, UDI (01)00801741073823(17)201228(10)

Lot Numbers:
NGFS1844
Product: Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device

Catalog A942216, Lot NGFS3274, UDI (01)00801741074110(17)201228(10)

Lot Numbers:
NGFS3274
Product: Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization Device

Catalog A902416, Lot NGFR4567, UDI (01)00801741074042(17)201228(10)

Lot Numbers:
NGFR4567
Product: Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device

Catalog A902916, Lots: NGFR3115, UDI (01)00801741074073(17)251228(10); NGFR3278, UDI (01)00801741074073(17)251228(10); NGFR3279, UDI (01)00801741074073(17)251228(10); NGFS1308, UDI (01)00801741074073(17)251228(10); NGFS1309, UDI (01)00801741074073(17)251228(10); and NGFS1366, UDI (01)00801741074073(17)251228(10)

Product: Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device

Catalog A943216, Lot NGEVX108, UDI (01)00801741100833(17)201228(10)

Lot Numbers:
NGEVX108
Product: Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device

Catalog A319516AM, Lot NGFS1691, UDI (01)00801741073892(17)201228(10); NGFR3282, UDI (01)00801741073892(17)201228(10); and NGFR4423, UDI (01)00801741073892(17)201228(10) Expanded 10/8/2021 adding Lot NGFS1691 UDI (01)00801741073892(17)201228(10)

Lot Numbers:
NGFS1691
NGFS1691
Product: Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device

Catalog A119216M; Lots NGFR2561, UDI (01)00801741073687(17)201228(10) and NGFS1312, UDI (01)00801741073687(17)201228(10)

Product: Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device

Catalog A300314A, Lot NGFR3627, UDI (01)00801741073724(17)201228(10)

Lot Numbers:
NGFR3627
Product: Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device

Catalog A300316A, Lots: NGEVX104 (exp. 08/31/2022), UDI (01)00801741073731(17)201228(10); NGFR3628 (02/28/2023), UDI (01)00801741073731(17)201228(10); GFS1114 (02/28/2023), UDI (01)00801741073731(17)201228(10); and NGFS1166 (02/28/2023), UDI (01)00801741073731(17)201228(10)

Product: Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device

Catalog A300318A, Lot NGEVX106, UDI (01)00801741073748(17)201228(10)

Lot Numbers:
NGEVX106
Product: Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device

Catalog A303316A, Lots: NGEVX103 (exp. 08/31/2022), UDI (01)00801741073793(17)201220(10); NGFR3290 (02/28/2023), UDI (01)00801741073793(17)201220(10); NGFR3291 (exp. 02/28/2023), UDI (01)00801741073793(17)201220(10); and NGFR4542 (exp. 02/28/2023) UDI (01)00801741073793(17)201220(10)

Product: Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device

Catalog A303318A, Lot NGEVX105, UDI (01)00801741073809(17)201220(10)

Lot Numbers:
NGEVX105
Product: Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device

Catalog A319416AM, Lots NGEVX107 (exp. 08/31/2022), UDI (01)00801741073861(17)201220(10); NGFR3116 (exp. 02/28/2023), UDI (01)00801741073861(17)201220(10); and NGFS1808 (02/28/2023) UDI (01)00801741073861(17)201220(10)

Product: Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device

Catalog A399400A, Lot NGFR3569, UDI (01)00801741073915(17)201228(10); Lot NGFR2691, UDI (01)00801741073915(17)201228(10) Expanded 10/8/2021 adding Lot NGFR2691, UDI (01)00801741073915(17)201228(10)

Lot Numbers:
NGFR3569
NGFR2691
NGFR2691
Product: Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

Catalog A800061, Lot NGFR3658, UDI (01)00801741104848(17)251228(10)

Lot Numbers:
NGFR3658
Product: Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

Catalog A800360, Lot NGFR3570, UDI (01)00801741073922(17)251228(10)

Lot Numbers:
NGFR3570
Product: Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

Catalog A800361, Lots: NGFR0310, UDI (01)00801741073939(17)201220(10); NGFR0311,UDI N(01)00801741073939(17)201220(10); GFR2807, UDI (01)00801741073939(17)201220(10); NGFR2829, UDI (01)00801741073939(17)201220(10); NGFR3571, UDI (01)00801741073939(17)201220(10); NGFR5475, UDI (01)00801741073939(17)201220(10); nd NGFR5481 UDI (01)00801741073939(17)201220(10)

Product: Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

Catalog A800365, Lots: NGFR3131, UDI (01)00801741073960(17)201220(10); NGFR3295, UDI (01)00801741073960(17)201220(10); NGFR4413, UDI (01)00801741073960(17)201220(10); NGFR4599, UDI (01)00801741073960(17)201220(10); and NGFS3150 UDI (01)00801741073960(17)201220(10)

Product: Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device

Catalog A897514, Lot NGFR2808, UDI (01)00801741104510(17)201228(10)

Lot Numbers:
NGFR2808
Product: Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device

Catalog A899916, Lot NGFR0101, UDI (01)00801741074011(17)251228(10)

Lot Numbers:
NGFR0101
Product: Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter

Catalog A902616, Lot NGFR3277, UDI (01)00801741104633(17)251228(10)

Lot Numbers:
NGFR3277

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88499
Status: Active
Manufacturer: C.R. Bard Inc
Manufactured In: United States
Units Affected: 21 products (10,150 units; 1760 units; 11,780 units; 350 units; 11,600 units; 420 units; 5950 units; 3980 units; 2660 units; 1140 units; 33,380 units; 18,060 units; 1710 units; 960 units; 80 units; 29,890 units; 40 units; 8170 units; 4830 units; 6440 units; 1440 units)
Agency Last Updated: October 27, 2021

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.