B. Braun Medical, Inc. Recall 87585
Description: Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications.
B. Braun Medical, Inc. Recall 87585 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1509-2021 |
| Event ID | 87585 |
| Event Description | Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of NC, CA. |
| Quantity | 1,900 units |
| Recall Reason | BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime. |
| Device Classification | 20210505 |
| Device Code Info | Lot #: 00SL713784, 0061741483, 0061755034, 0061755296 |
| Center Classification Date | 20210429 |
| Recall Initiation Date | 20210315 |
| Recalling Firm | B. Braun Medical, Inc. |
| Initial Notification | Letter |
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