FDA-Device2024-10-02Class II
Neuro Vascular, ANKV91A; Medical convenience kit
American Contract Systems, Inc.
Hazard
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Sold states
US Nationwide distribution in the states of MO, MN, MA, OH, NE.
Affected count
1 unit
Manufactured in
2610 Ne Industrial Dr Ste 220, Kansas City, MO, United States
Products
Neuro Vascular, ANKV91A; Medical convenience kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3236-2024Don't want to check this manually?
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