Southmedic product recalled over sterility concerns
- Recall date
- November 6, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Southmedic, Inc. recalls Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for prepar…
- Recall number
- Z-1892-2018
- FDA classification
- Class II
- Brand / firm
- Southmedic, Inc.
- Sold / distributed
- US Distribution to the states of : IA, IL, NE, NY and TX
Why it was recalled
Scalpels lot contains non-sterile products labeled as sterile.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
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