Abiomed, Inc.: Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0

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

Details from the source

Reason for recall: 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 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: 2 units within kit Lot/code info: UDI-DI: N/A

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.