Z-1603-2020Class II

Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039

Name: Z-1603-2020 Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2020-02-20
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2020-02-20 / Terminated

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 on 2020-02-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1603-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-20
Posted: 2020-03-27
Terminated: 2022-01-18
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Product code: DRE Dilator, Vessel, For Percutaneous Catheterization
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.
FDA 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 in commerce: 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
Product codes and lots: Lot 19-03466

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1603-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1603-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-27

Product code DRE

K081940Class IIAvalon Elite Vascular Access KitAvalon Laboratories, LLC / cleared 2008-11-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)