Aesculap Implant Systems LLC recalls Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, prod…
- Recall date
- October 1, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1449-2022
- FDA classification
- Class II
- Brand / firm
- Aesculap Implant Systems LLC
- Sold / distributed
- United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI
Why it was recalled
Packaging seal integrity not validated resulting in a lack of sterility assurance.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
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