Food, drugs, devices › C.R. Bard Inc
Device recall: Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Devic
FDA enforcement event 88499 is a device recall by C.R. Bard Inc of Covington, GA, initiated 5 Aug 2021 and classified Class II, with 21 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. C.R. Bard Inc has 49 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
C.R. Bard Inc, Covington, GA.
Reason for recall
"There is potential for packaging defects that may impact the sterile barrier."
Distribution
"US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2521-2021 | Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device | 10,150 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2522-2021 | Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device | 1760 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2523-2021 | Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device | 11,780 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2524-2021 | Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device | 350 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2525-2021 | Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device | 11,600 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2526-2021 | Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device | 420 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2527-2021 | Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device | 5950 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2528-2021 | Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device | 3980 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2529-2021 | Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray | 2660 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2530-2021 | Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray | 1140 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2531-2021 | Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray | 33,380 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2532-2021 | Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray | 18,060 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2533-2021 | Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device | 1710 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2534-2021 | Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device | 960 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2535-2021 | Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter | 80 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2536-2021 | Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device | 29,890 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2537-2021 | Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device | 40 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2538-2021 | Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device | 8170 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2539-2021 | Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization Device | 4830 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2540-2021 | Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device | 6440 units | Class II | Ongoing | 29 Sep 2021 |
| Z-2541-2021 | Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device | 1440 units | Class II | Ongoing | 29 Sep 2021 |
Context
Other enforcement events for C.R. Bard Inc
All 49 events for C.R. Bard Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There is potential for packaging defects that may impact the sterile barrier."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.