Z-1603-2020 Class II Terminated
FDA device recall Z-1603-2020 was initiated by Maquet Cardiovascular Us Sales, Llc on February 20, 2020 and is designated Class II. 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 … The recall status is terminated (terminated January 18, 2022). Affected quantity: 255.
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2020
- Initiation Date
- February 20, 2020
- Termination Date
- January 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 255
Product Description
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
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.
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
Code Information
Lot 19-03466