Recall Z-1603-2020— Maquet Cardiovascular Us Sales, Llc

Name: FDA recall Z-1603-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-20

Class II · Terminated

Class II FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2020-02-20, terminated 2022-01-18. It names one FDA 510(k) clearance: K081940. Product: Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039. 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..

Recalling firm: Maquet Cardiovascular Us Sales, Llc
Classification: Class II
Status: Terminated
Initiated: 2020-02-20
Terminated: 2022-01-18
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K081940 — AVALON ELITE VASCULAR ACCESS KITAvalon Laboratories, LLC·cleared 2008-11-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.