FDA Device recall Z-0930-2021
B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sa…
- FDA Device
- Class II
- ongoing
- Published 2021-02-03
On 2021-02-03 the FDA classified a Class II recall of B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sa… by Braxton Medical, citing recalled products do not have FDA approval for sale in the United States.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0930-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-09-04 |
| Published | 2021-02-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Braxton Medical |
| Distribution | US |
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
Recalled products do not have FDA approval for sale in the United States.
Identifiers
| code_info | All lot numbers under item codes ending in -01: 4251601-01, 4251628-01, 4251652-01, 4251687-01, 4251890-01, 4252500-01,…All lot numbers under item codes ending in -01: 4251601-01, 4251628-01, 4251652-01, 4251687-01, 4251890-01, 4252500-01, 4252519-01, 4252527-01, 4252535-01, 4252543-01, 4252560-01, 4252586-01, 4252594-01, 4253523-01, 4253540-01, 4254546-01. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0930-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.