CLASS II ONGOING Device recall · Reported 29 Sep 2021 · FDA Enforcement Report
Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag recalled
C.R. Bard is recalling Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, 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-2534-2021
- 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
- Other Medical 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 A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
There is potential for packaging defects that may impact the sterile barrier.
Which lots are affected?
Catalog A899916, Lot NGFR0101, UDI (01)00801741074011(17)251228(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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
20 other products · FDA event 88499This product is part of a recall event; the main page for the event is Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete recalled.
More recalls from C.R. Bard
All 123| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Temperature Abuse | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Temperature Abuse | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |