BARD SureStep Foley Tray System Bardex I — Class II medical device recall Z-0800-2019
Ongoing recall by Bard Medical Division, reported 2019-02-13, distributed nationwide. Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented
| Recall number | Z-0800-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Medical Division, Covington, GA, United States |
| Recall initiated | 2018-12-06 |
| Classified | 2019-02-05 |
| Reported by FDA | 2019-02-13 |
| Distributed | Nationwide (US) |
| Quantity | 450 units |
| Reason classes | packaging |
| Lot numbers | NGCT1929 |
| Expiration dates | 2018-11-30 |
Product
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.
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.
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-0800-2019. 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.