Aspiration Syringe Kit MVSK60 Inadvertently Shipped with OUS Labeling
MicroVention's Aspiration Syringe Kit (REF: MVSK60) was labeled for international distribution but inadvertently shipped to U.S. customers. The affected lot (H2146461) was distributed to Alabama, Nevada, and New York.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This Class II medical device recall involves a labeling and distribution error in which kits intended for international (OUS) distribution were shipped to U.S. customers. No illnesses, injuries, or deaths have been reported, and the hazard is administrative rather than an inherent product defect.
Plain-English summary
MicroVention Inc. has recalled Aspiration Syringe Kit models REF: MVSK60 due to a shipping error. The affected kits were labeled for outside-U.S. (OUS) distribution but were inadvertently shipped to U.S. customers. A total of 33 units in lot H2146461 were affected.
The incorrectly distributed kits reached facilities in Alabama, Nevada, and New York. Healthcare providers who received this product should discontinue use and contact the manufacturer for appropriate return or replacement instructions.
No illnesses or injuries have been reported as of this recall notice. For additional information or to return the product, customers should contact MicroVention Inc. directly.
The recalled product
- Product
- Aspiration Syringe Kit, REF: MVSK60
- Manufacturer
- MICROVENTION INC.
- Hazard
- Affected units
- 33
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 (2)
- Lot: H2146461
- UDI: (01)00816777025906(11)210727(17)240430(10)H2146461
Distribution
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