CLASS II ONGOING Device recall · Reported 13 Feb 2019 · FDA Enforcement Report
BARD SureStep Foley Tray System Bardex I.C recalled
Bard Medical Division is recalling BARD SureStep Foley Tray System Bardex I.C, distributed nationwide in the US. The recall was initiated on 6 Dec 2018 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-0800-2019
- FDA event ID
- 81750
- Recalling firm
- Bard Medical Division, Covington, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Dec 2018
- FDA classified
- 5 Feb 2019
- Reported
- 13 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 6 Dec 2018 | Recall initiated by company | |
| 5 Feb 2019 | Classified by FDA | +61 days |
| 13 Feb 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port.
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
BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.
Where it was distributed
US Nationwide Distribution io KY, NE, GA, FL, MS, IN, IL, VA, OK, TX, NM, IL, VA, PA, CA, NV.
Nationwide CaliforniaFloridaGeorgiaIllinoisIndianaKentuckyMississippiNebraskaNew MexicoNevadaOklahomaPennsylvaniaTexasVirginia
Questions about this recall
Is BARD SureStep Foley Tray System Bardex I.C recalled?
Yes. Bard Medical Division recalled BARD SureStep Foley Tray System Bardex I.C on 6 Dec 2018. The recall is Class II and its status is Ongoing. Recall number Z-0800-2019.
Why was it recalled?
Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port.
Which lots are affected?
Product Code A319418AM; Lot NGCT1929; Exp. Date 11/30/2018
Where was it sold?
US Nationwide Distribution io KY, NE, GA, FL, MS, IN, IL, VA, OK, TX, NM, IL, VA, PA, CA, NV.
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 Bard Medical Division
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medivance(R) Arctic Sun(R) Arcticgel(TM) Pads: Description recalled | Bard Medical Division | Temperature Abuse | Nationwide |
| Device | CLASS II | SureStep(TM) Foley Tray System recalled by Bard Medical Division | Bard Medical Division | Packaging Defects | GA |
| Device | CLASS II | Bard Midstream Urine Collector with Rigid Funnel recalled | Bard Medical Division | Potency & Assay | 24 states |
| Device | CLASS II | Arctic Sun Temperature Management System recalled | Bard Medical Division | Temperature Abuse | 51 states |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| 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 | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |