Abiomed, Inc. Recall 93501
Description: Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025
Abiomed, Inc. Recall 93501 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0653-2024 |
| Event ID | 93501 |
| Event Description | Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025 |
| Product Type | Devices |
| Distribution | Nationwide Foreign: Country AT AU BE BR CA CA CH CZ DE DK ES FR FR HK IN IT MX MY NL NO PA SG TW UK |
| Quantity | 1 unit within kit |
| Recall Reason | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis |
| Device Classification | 20240117 |
| Device Code Info | UDI-DI: N/A |
| Center Classification Date | 20240105 |
| Recall Initiation Date | 20231107 |
| Recalling Firm | Abiomed, Inc. |
| Initial Notification | Letter |
| Similar To |