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 |
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