FDA-Device2020-01-01Class II
Lamicel 20PK 3MM INTL Cervical dilator
Medtronic Xomed, Inc.
Hazard
Routine sterilization dose does not meet the required Sterility Assurance Level.
Sold states
Affected product was only distributed in Japan.
Affected count
29320 units
Manufactured in
6743 Southpoint Dr N, Jacksonville, FL, United States
Products
Lamicel 20PK 3MM INTL Cervical dilator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0733-2020Don't want to check this manually?
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