Maquet Cardiovascular Us Sales, Llc Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Brand
Maquet Cardiovascular Us Sales, Llc
Lot Codes / Batch Numbers
Lot 19-03466
Products Sold
Lot 19-03466
Maquet Cardiovascular Us Sales, Llc is recalling Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 due to 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 a. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On February 20, 2020, the recalling firm notified affected customers via Urgent Medical Device Recall letters sent through FedEx. Customers were informed of the material mix-up with the needle portion of the kit. Customers were instructed to immediately examine their inventory to determine if they have any of the affected lot. If so, please remove the kits from areas of use and return the product to Getinge following the instructions in the letter. Unused and unexpired affected product that is returned to Getinge is eligible for full credit.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, CT, FL, GA, IL, MA, MI, NH, NM, NY, NC, OH, OK, TN, TX, VA
Page updated: Jan 10, 2026