CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191 — Class II medical device recall Z-2474-2019
Terminated recall by B. Braun Medical, Inc., reported 2019-09-11, distributed in AL, CA, FL, GA, IL, MN, MO, NC…. The filter capacity is not achieved due to damage of the filter membrane.
| Recall number | Z-2474-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2019-07-10 |
| Classified | 2019-09-05 |
| Reported by FDA | 2019-09-11 |
| Terminated | 2020-08-21 |
| Distributed | AL, CA, FL, GA, IL, MN, MO, NC, PA, TX |
| Quantity | 1,230 units |
| UPC / GTIN / UDI-DI | 04046964941474 |
| Lot numbers | 0061536641, 0061643652 |
| Model numbers | 339191 |
| Expiration dates | 2018-10-31, 2019-11-30 |
Product
CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191
Reason for recall
The filter capacity is not achieved due to damage of the filter membrane.
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-2474-2019. 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.