Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
This recall has been terminated (originally issued February 20, 2020).
- Recall Initiated
- February 20, 2020
- Terminated
- January 18, 2022
- Recall Number
- Z-1603-2020
- Quantity
- 255
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
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
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
Lot / Code Info
Lot 19-03466
Root Cause
Under Investigation by firm
Action Taken
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.