Class II — C.R. Bard Inc
| Recalling firm | C. R. Bard, Inc. |
|---|---|
| Registered facility | View this company's 19 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is potential for a white paper-type residue attached to the catheter. |
| Product | 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 catheter, such as a nephrostomy tract. |
| Quantity | 8392 units |
| 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. |
| Initiated | 2020-04-15 |
| Classified | 2020-05-13 |
| Terminated | 2021-05-20 |
| Recall number | Z-1970-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — C.R. Bard Inc (Z-1970-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85585/
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