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Abiomed, Inc. recalls Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part
Recalled January 17, 2024 · FDA recall Z-0649-2024 · Abiomed
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. · FDA Class II
Units
193 single units; 1034 units within kits
Sold at
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
Description
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.
Product
Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body
Manufacturer(s)
Abiomed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →