CLASS II ONGOING Device recall · Reported 29 Sep 2021 · FDA Enforcement Report
Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley recalled
C.R. Bard is recalling Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley, distributed nationwide in the US. The recall was initiated on 5 Aug 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2532-2021
- FDA event ID
- 88499
- Recalling firm
- C.R. Bard, Covington, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Aug 2021
- FDA classified
- 23 Sep 2021
- Reported
- 29 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 5 Aug 2021 | Recall initiated by company | |
| 23 Sep 2021 | Classified by FDA | +49 days |
| 29 Sep 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is potential for packaging defects that may impact the sterile barrier.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley recalled?
Yes. C.R. Bard recalled Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley on 5 Aug 2021. The recall is Class II and its status is Ongoing. Recall number Z-2532-2021.
Why was it recalled?
There is potential for packaging defects that may impact the sterile barrier.
Which lots are affected?
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)
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from C.R. Bard
All 117| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Silastic Foley Catheters Silastic Foley Catheter 30cc recalled | C.R. Bard | Other | 44 states |
| Device | CLASS II | BD InLay Optima Ureteral Stent Kit Size:., Ureteral Stent Kit recalled | C.R. Bard | Device Malfunction | Nationwide |
| Device | CLASS II | BD InLay Optima Ureteral Stent Kit Size:., Ureteral Stent Kit recalled | C.R. Bard | Device Malfunction | Nationwide |
| Device | CLASS II | Bard InLay Optima Size:., Ureteral Stent Kit recalled by C.R. Bard | C.R. Bard | Device Malfunction | Nationwide |
| Device | CLASS II | BD InLay Optima Ureteral Stent Kit Size:., Ureteral Stent Kit recalled | C.R. Bard | Device Malfunction | Nationwide |
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All 6,190| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |