SureStep Foley Tray System — Class II medical device recall Z-1970-2020
Terminated recall by C.R. Bard Inc, reported 2020-05-20, distributed nationwide. There is potential for a white paper-type residue attached to the catheter.
| Recall number | Z-1970-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard Inc, Covington, GA, United States |
| Recall initiated | 2020-04-15 |
| Classified | 2020-05-13 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2021-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 8,392 units |
| UPC / GTIN / UDI-DI | 00801741104299 |
| Lot numbers | NGDX4745 |
| Model numbers | A304716A |
| Expiration dates | 2021-03-20, 2021-11-30 |
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.
Reason for recall
There is potential for a white paper-type residue attached to the catheter.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1970-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.