FDA-Device2024-08-14Class II
American Contract Systems Hand Pack convenience kit
American Contract Systems, Inc.
Hazard
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Sold states
US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
Affected count
90
Manufactured in
2610 Ne Industrial Dr Ste 220, Kansas City, MO, United States
Products
American Contract Systems Hand Pack convenience kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2517-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief