Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Reported: April 8, 2020 Initiated: February 20, 2020 #Z-1603-2020
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.
Details
- Recalling Firm
- Maquet Cardiovascular Us Sales, Llc
- Units Affected
- 255
- Distribution
- 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
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039. Recalled by Maquet Cardiovascular Us Sales, Llc. Units affected: 255.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 8, 2020. Severity: Moderate. Recall number: Z-1603-2020.
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