FDAFDA · Food and drugs·Recall number Z-0653-2024
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
Published January 17, 2024 · Recall initiated: November 7, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abiomed, Inc.
- Distributor
- 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
- Lot
- UDI-DI: N/A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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