Medtronic Xomed, Inc. recalls Lamicel 20PK 3MM INTL Cervical dilator
- Recall date
- November 13, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0733-2020
- FDA classification
- Class II
- Brand / firm
- Medtronic Xomed, Inc.
- Sold / distributed
- Affected product was only distributed in Japan.
Why it was recalled
Routine sterilization dose does not meet the required Sterility Assurance Level.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Lamicel 20PK 3MM INTL Cervical dilator
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