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Recall Observatory FDA recall evidence

Device product

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

Z-0653-2024

November 07, 2023

Class II

Product summary

Firm
Abiomed, Inc.
Event
Event 93501
Status
Ongoing
Classification
Class II
Quantity
1 unit within kit
Official record key
device-enforcement:Z-0653-2024

Official wording

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

Code information: UDI-DI: N/A

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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