Food, drugs, devices › C.R. Bard Inc
Device recall: SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of uri
C.R. Bard Inc (Covington, GA) initiated this device recall on 15 Apr 2020; FDA lists 1 product record under event 85585, classified Class II.
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. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 20 May 2021. 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 a white paper-type residue attached to the catheter."
Distribution
"US Nationwide distribution including in the states of AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MO, NC, NE, NJ, NY, RI, SD, TN, TX, UT, VA, WV."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1970-2020 | SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the… | 8392 units | Class II | Terminated | 20 May 2020 |
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 a white paper-type residue attached to the catheter."
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 including in the states of AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MO, NC, NE, NJ, NY, RI, SD, TN, TX, UT, VA, WV."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 May 2021. "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.