Catalog A399400A — Class II medical device recall Z-2528-2021
Ongoing recall by C.R. Bard Inc, reported 2021-09-29, distributed nationwide. There is potential for packaging defects that may impact the sterile barrier.
| Recall number | Z-2528-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard Inc, Covington, GA, United States |
| Recall initiated | 2021-08-05 |
| Classified | 2021-09-23 |
| Reported by FDA | 2021-09-29 |
| Distributed | Nationwide (US) |
| Quantity | 3,980 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00801741073915 |
| Lot numbers | NGFR2691, NGFR3569 |
| Model numbers | A399400A |
Product
Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device
Reason for recall
There is potential for packaging defects that may impact the sterile barrier.
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-2528-2021. 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.