Product Safety Recalls

Product Recall Tracker

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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0653-2024
Event ID93501
Event DescriptionOscor 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 TypeDevices
DistributionNationwide 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
Quantity1 unit within kit
Recall ReasonHole(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 Classification20240117
Device Code InfoUDI-DI: N/A
Center Classification Date20240105
Recall Initiation Date20231107
Recalling FirmAbiomed, Inc.
Initial Notification Letter
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