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Recall Observatory FDA recall evidence

Device product

Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039

Z-1603-2020

February 20, 2020

Class II

Product summary

Firm
Maquet Cardiovascular Us Sales, Llc
Event
Event 85104
Status
Terminated
Classification
Class II
Quantity
255
Official record key
device-enforcement:Z-1603-2020

Official wording

Reason: A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled with an incorrect Arterial Access Needle instead of a Multi-Purpose Procedure Needle.

Code information: Lot 19-03466

Distribution pattern: Domestic distribution only to the following states: AL AZ CA CT FL GA IL MA MI NC NH NM NY OH OK TN TX VA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled with an incorrect Arterial Access Needle instead of a Multi-Purpose Procedure Needle.