Braxton Medical Corporation Recall 86443
Description: 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.
Braxton Medical Corporation Recall 86443 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0930-2021 |
| Event ID | 86443 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution including in the states of AL, CA, CT, FL, GA, IL, KS, LA, MI, MN, NC, NJ, NY, PA, SD, TX, WA. |
| Quantity | 1,781 cases |
| Recall Reason | Recalled products do not have FDA approval for sale in the United States. |
| Device Classification | 20210203 |
| Device Code Info | 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. |
| Center Classification Date | 20210127 |
| Recall Initiation Date | 20200904 |
| Recalling Firm | Braxton Medical Corporation |
| Initial Notification | Letter |
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