The Recall Desk
ModerateFDA (Devices)·Z-0202-2022·Announced 2021-11-10

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.

What this means for you

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
  • labeling-error

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

Distributed nationwide across the United States.