medical Class II Updated 2020-04-08

Maquet Cardiovascular Us Sales, Llc recalls Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: AL, AZ, CA, CT, FL, GA, IL, MA, MI, NC, NH, NM, NY, OH, OK, TN, TX, VA
Lot/Code Info: Lot 19-03466
View official government recall

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