HUMAN MED AG Recall 96137
Description: human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
HUMAN MED AG Recall 96137 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1251-2025 |
| Event ID | 96137 |
| Event Description | human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of FL. |
| Quantity | 775 devices |
| Recall Reason | The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet. |
| Device Classification | 20250312 |
| Device Code Info | Lot number 24-20198, UDI (01)04260170881014(11)240611(17)270611(10)24-20198; and Lot number 23-19612, UDI (01)04260170881014(11)240109(17)270109(10)23-19612. |
| Center Classification Date | 20250228 |
| Recall Initiation Date | 20241018 |
| Recalling Firm | HUMAN MED AG |
| Initial Notification | Letter |
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