FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular Us Sales, Llc: Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
- Recall number
- Z-1603-2020
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Product
- Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
- Status
- Terminated
- Initiated
- 2020-02-20
- Posted
- not on file
- Terminated
- 2022-01-18
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- 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
- Lot, serial or model codes
- Lot 19-03466
- 510(k) numbers
- ["K081940"]
- PMA numbers
- not on file
- Product code
- DRE
- Firm FEI
- 3008355164
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28