Avalon Elite Vascular Access Kit recall
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Why was Avalon Elite Vascular Access Kit 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 19-03466
- Product
- Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Quantity
- 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
- Recall date
- April 8, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)