FDA-Device2024-10-02Class II
Endovascular AAA Pack, ESED52B; 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
360 units
Manufactured in
2610 Ne Industrial Dr Ste 220, Kansas City, MO, United States
Products
Endovascular AAA Pack, ESED52B; Medical convenience kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3228-2024Don't want to check this manually?
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