FDA-Device2022-09-14Class II
Various PICC Line, Central Line Packs
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
2 units
Manufactured in
2610 Ne Industrial Dr Ste 220, N/A, Kansas City, MO, United States
Products
Various PICC Line, Central Line Packs
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1692-2022Don't want to check this manually?
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