Food, drugs, devices › Maquet Cardiovascular Us Sales, Llc
Device recall: Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
FDA enforcement event 85104 is a device recall by Maquet Cardiovascular Us Sales, Llc of Wayne, NJ, initiated 20 Feb 2020 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 18 Jan 2022. Initiation: voluntary: firm initiated. Maquet Cardiovascular Us Sales, Llc has 40 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Maquet Cardiovascular Us Sales, Llc, Wayne, NJ.
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"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1603-2020 | Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 | 255 | Class II | Terminated | 8 Apr 2020 |
Context
Other enforcement events for Maquet Cardiovascular Us Sales, Llc
All 40 events for Maquet Cardiovascular Us Sales, Llc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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 Multi-Purpose Procedure Needle."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Jan 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.