Maquet Recalls Avalon Elite Vascular Access Kits Due to Needle Mix-up
Maquet is recalling 255 Avalon Elite Vascular Access Kits because 81 units were assembled with an incorrect arterial needle instead of a multi-purpose needle.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a component mismatch that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 255 units of the Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039. The recall is due to a material mix-up during assembly where 81 of the kits were equipped with an incorrect Arterial Access Needle instead of the intended Multi-Purpose Procedure Needle.
The affected kits, identified by Lot 19-03466, were distributed domestically to facilities in Alabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Michigan, North Carolina, New Hampshire, New Mexico, New York, Ohio, Oklahoma, Tennessee, Texas, and Virginia.
Healthcare providers and consumers should stop using the affected kits and contact Maquet Cardiovascular for instructions on return or replacement.
The recalled product
- Product
- Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 255
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 19-03466
Distribution
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