B — Class II medical device recall Z-0930-2021
Ongoing recall by Braxton Medical Corporation, reported 2021-02-03, distributed nationwide. Recalled products do not have FDA approval for sale in the United States.
| Recall number | Z-0930-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Braxton Medical Corporation, Lutz, FL, United States |
| Recall initiated | 2020-09-04 |
| Classified | 2021-01-27 |
| Reported by FDA | 2021-02-03 |
| Distributed | Nationwide (US) |
| Quantity | 1,781 cases |
Product
B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.
Reason for recall
Recalled products do not have FDA approval for sale in the United States.
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-0930-2021. 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.