Maquet Cardiovascular Us Sales, Llc: Medical Device Recall in 2020 - (Recall #: Z-1603-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 20, 2020

Date Posted: April 8, 2020

Recall Number: Z-1603-2020

Event ID: 85104

Reason for Recall:

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.

Status: Terminated

Product Quantity: 255

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

Voluntary or Mandated:

Voluntary: Firm initiated