FDA-Device2022-09-14Class II
Various Angiography/Cath Lab packs/trays
American Contract Systems, Inc.
Hazard
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Sold states
Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX
Affected count
61 units
Manufactured in
2610 Ne Industrial Dr Ste 220, N/A, Kansas City, MO, United States
Products
Various Angiography/Cath Lab packs/trays
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1690-2022Don't want to check this manually?
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