B Braun Medical Inc Recall 90830
Description: Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
B Braun Medical Inc Recall 90830 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0009-2023 |
| Event ID | 90830 |
| Event Description | Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access. |
| Product Type | Devices |
| Distribution | Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada |
| Quantity | 94,000 US |
| Recall Reason | Potential for leakage at the catheter hub. |
| Device Classification | 20221012 |
| Device Code Info | UDI-DI (GTIN): 04046963318154 Lot Number/Expiration Date: 22D04G8241 01 Apr 2027 22D07G8241 01 Apr 2027 22D07G8242 01 Apr 2027 22E30G8241 01 May 2027 22E30G8242 01 May 2027 |
| Center Classification Date | 20221006 |
| Recall Initiation Date | 20220901 |
| Recalling Firm | B Braun Medical Inc |
| Initial Notification | Letter |
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